The Philippine

National Deployment
and Vaccination Plan
for COVID-19
Vaccines
Interim Plan
January 2021
Foreword
The COVID-19 pandemic has drastically affected our society over the past year. Globally, there are
more than 90 million confirmed cases and 2 million deaths. Among these are half a million Filipinos
that are confirmed cases and nearly ten thousand deaths. The pandemic has also disrupted the
economy, causing a nine percent contraction in the first half of 2020 and increased unemployment
rate to 17.7 percent. While we are resuming economic activities and getting used to the “New
Normal”, fear and uncertainty will remain as long as there is the risk of us or our loved ones getting
infected or while how or when the pandemic will end remains unknown.

The development of the vaccine against COVID-19 is among the solutions that give hope to society
in beating the pandemic and the government aims to provide safe and effective vaccines to protect
all Filipinos from COVID-19. However, the supply of vaccines is scarce and the effects of the vaccine
have not been fully observed in some population groups. Thus, to understand the rationale for the
strategies employed, the reader should be aware of the principles applied in planning the deployment
and distribution of the vaccine which are described in one of the sections of this document.

Combatting the COVID-19 pandemic requires a whole-of-government and whole-of-society

approach. Cooperation between national government agencies, local government units, various
sectors of society, and especially communities and individuals, is necessary to prevent transmission
of the virus so the economy returns to normal. While the vaccine is among the solutions, it is not the
only solution to end the pandemic. It is also important for individuals to adhere to minimum public
health standards, make smart choices and have safe behaviors and for the health sector to conduct
effective surveillance and contact tracing and have adequate capacity to manage the sick.

The Department of Health, through the Task Group COVID-19 Immunization Program, has
diligently worked on this comprehensive plan for vaccine deployment and vaccination in
collaboration with other national government agencies under the COVID-19 Vaccine Cluster. This
document will help unify the efforts of all stakeholders to effectively implement the National
Deployment and Vaccination Plan for COVID-19 Vaccines and inform the general population on
the plans of the government. We hope the combined efforts of all stakeholders will lead to effective
delivery of the COVID-19 vaccines and contribute to better health outcomes for Filipinos.
Acknowledgement
The Philippine National Deployment and Vaccination Plan for COVID-19 Vaccines (NDVP) was
developed by the Philippine Government under the leadership of President Rodrigo Roa Duterte,
and under the guidance of Health Secretary Franscisco T. Duque III and COVID-19 Vaccine
Cluster Chair, Secretary Carlito G. Galvez Jr.

All government agencies under the COVID-19 Vaccine Cluster have contributed in the
development of this plan: Office of the President (OP), Office of the Chief Presidential Legal
Counsel (OCPLC), Department of Health (DOH), Department of Science and Technology
(DOST), Food and Drug Administration (FDA), Research Institute for Tropical Medicine
(RITM), Department of Trade and Industry (DTI), Department of Foreign Affairs (DFA),
National Development Company (NDC), Department of Finance (DOF), Department of Budget
and Management (DBM), Department of Interior and Local Government (DILG), Department of
Social Welfare and Development (DSWD), Department of Education (DepEd), Department of
National Defense (DND), Department of Information and Communications Technology (DICT),
Department of Transportation (DOTr), Department of Justice (DOJ), Department of Labor and
Employment (DOLE), Armed Forces of the Philippines (AFP), Office of Civil Defense (OCD),
Philippine National Police (PNP), Bureau of Corrections (BuCor), Bureau of Jail Management and
Penology (BJMP), and Task Group Resource Management and Logistics (TGRML) under the
National Task Force Against COVID-19.

The Task Group COVID-19 Immunization Program, under the guidance of Undersecretary Myrna
C. Cabotaje and Director Napoleon Arevalo, consolidated and ensured the completion of this plan.
Further, special thanks to the following for doing the technical writing, editing and proofreading:
Dr. Marianne B. Calnarv, Dr. Rhodora S. Cruz, Ms. Christine Joy Candari, Dr. Kezia Lorraine
Rosario, Dr. Shaymae Ufano, Mr. Jay Dulay, Dr. Sarah Lazaga, Mr. Venjie Benito and Ms. Rowena
J. Capistrano.

The contributions and insights of everyone are truly appreciated.

List of Acronyms

AEFI Adverse Event Following Immunization

AESI Adverse Event of Special Interest
AFP Armed Forces of the Philippines
API Application Program Interface
BHERTs Barangay Health Emergency Response Teams
BJMP Bureau of Jail Management and Penology
BuCor Bureau of Corrections
CEIR COVID-19 Electronic Immunization Registry
CHD Center for Health Development
CHO City Health Office
CIOMS Council for International Organizations of Medical Sciences
COVID-19 Coronavirus Disease 2019
CPG Clinical Practice Guidelines
CPR Certificate Product of Registration
CSO Civil Society Organization
DBM Department of Budget and Management
DENR Department of Environment and Natural Resources
DepEd Department of Education
DFA Department of Foreign Affairs
DICT Department of Information and Communications Technology
DILG Department of Interior and Local Government
DND Department of National Defense
DOF Department of Finance
DOH Department of Health
DOJ Department of Justice
DOLE Department of Labor and Employment
DOST Department of Science and Technology
DOTr Department of Transportation
DPA Data Privacy Act
DPCB Disease Prevention and Control Bureau
DSWD Department of Social Welfare and Development
DTI Department of Trade and Industry
EB Epidemiology Bureau
EO Executive Order
ESU Epidemiology and Surveillance Unit
EUA Emergency Use Authorization
EXECOM Executive Committee
FDA Food and Drug Administration
GAA General Appropriations Act
GAVI Global Alliance for Vaccines and Immunization
GFI Government Financial Institutions
GOCC Government-owned and Controlled Corporation
H1N1 Influenza A virus subtype H1N1
HCWM Health Care Waste Management
HEMB Health Emergency Management Bureau
HIS Health Information System
HPDPB Health Policy Development and Planning Bureau
HTAC Health Technology Assessment Council
HUC Highly Urbanized Cities
IATF-EID Inter-Agency Task Force on Emerging Infectious Diseases
ICC Independent Component Cities
ICT Information and Communication Technology
IHR International Health Regulation
IPC Infection Prevention Control
JV Joint Venture
KMITS Knowledge Management and Information Technology Service
LCE Local Chief Executive
LGU Local Government Unit
MERS-CoV Middle East Respiratory Syndrome Coronavirus
MOH-BARMM Ministry of Health-Bangsamoro Autonomous Region of Muslim Mindanao
MR-OPV SIA Measles-Rubella Oral Polio Vaccine Supplemental Immunization Activity
NAEFIC National Adverse Events Following Immunization Committee
NAP National Action Plan
NART National AEFI Response Team
NCDA National Council on Disability Affairs
NDA Non-Disclosure Agreement
NDC National Development Company
NDVP National Deployment and Vaccination Plan
NEDA NAtional Economic Development Authority
NIP National Immunization Program
NITAG National Immunization Technical Advisory Group
NPC National Privacy Commission
NRA National Regulatory Authority
NTC National Telecommunications Commission
NTF National Task Force
OCD Office of Civil Defense
OCPLC Office of the Chief Presidential Legal Counsel
ODA Official Development Assistance
OHCS One Hospital Command System
OP Office of the President
PCG Philippine Coast Guard
PCHRD Philippine Council for Health Research and Development
PCOO Presidential Communications Operations Office
PDL Persons Deprived of Liberty
PDOHO Provincial DOH Office
PHEIC Public Health Emergency of International Concern
PHO Provincial Health Office
PIA Philippine Information Agency
PIC Personal Information Controllers
PIDSR Philippine Integrated Disease Surveillance and Response
PIP Personal Information Processors
PNP Philippine National Police
PPE Personal Protective Equipment
PWD Persons with Disability
RHU Rural Health Unit
RITM Research Institute of Tropical Medicine
RMP Risk Management Plan
rVSV-ZEBOV Recombinant Vesicular Stomatitis Virus-Zaire Ebola Virus
SARS-CoV-2 Severe Acute Respiratory Syndrome Coronavirus 2
SAGE Strategic Advisory Group of Experts
SCB Safety Collector Boxes
SOP Standard Operating Procedure
STG Sub-Task Group
TG Task Group
TGRML Task Group Resource Management and Logistics
UNICEF United Nations Children’s Fund
VAL Vaccination Administration Location
VEP Vaccine Expert Panel
VIMS Vaccine Information Management System
VIRAT Vaccine Introduction Readiness Assessment Tool
VOC Vaccination Operation Center
WHO World Health Organization
Table of Contents
Foreword ii
Acknowledgement iii
List of Acronyms iv
Executive Summary x
Introduction 1
Background 1
Rationale for the National Deployment and Vaccination Plan 2
Target Audience 2
Dissemination of the Plan 3
Guiding Principles 3
Process for Developing the Plan 5
Lay-out of the Plan 5
Governance 6
Risk Communication and Community Engagement 21
Registry and Data Management 31
Chapter 1: Vaccine Selection and Evaluation 35
Chapter 2: Diplomatic Negotiation and Engagement 38
Regulatory Preparedness 38
Vaccines Access 40
Chapter 3: Procurement and Financing 42
Chapter 4: Shipment and Storage 45
Supply Chain 46
Cold Chain Management 47
Chapter 5: Vaccine Distribution and Deployment 50
Determining the Vaccine Recipients 50
Vaccine Deployment Strategies 56
Vaccine Distribution Strategies 58
Chapter 6: Implementation of a Nationwide Vaccination 60
Pre-implementation Phase 60
Implementation Phase 91
Chapter 7: Assessment, Evaluation and Monitoring 105
Vaccine Safety Monitoring, and Management of AEFI 105
Safety Surveillance and Responses 112
Monitoring and Evaluation Framework, and Reporting Mechanism 124
Executive Summary
This document describes the National Deployment and Vaccination Plan for COVID-19 vaccines.
It is comprised of an Introduction, Special Chapters, and the Main Chapters for the seven phases of
the plan, namely: Scientific Evaluation and Selection, Access and Acquisition, Procurement and
Financing, Shipment and Storage, Distribution and Deployment, Implementation of Nationwide
Vaccination, and Assessment, Monitoring, and Evaluation.

The Introduction provides the rationale, guiding principles, and process for development of the
Plan. The Special Chapters includes discussion on the governance structure of the deployment and
vaccination program, the risk communication and community engagement, and the vaccination
registry and data management of vaccination information.

The first chapter in the Main Chapters section is the Scientific Evaluation and Selection which
defines the criteria to be used in evaluating the COVID-19 vaccines and the prioritization
mechanism for the vaccines that will be initially considered for evaluation.

The second chapter is the Diplomatic Negotiation and Engagement which describes the process of
engagement of the government with foreign entities as to the vaccine development, evaluation, and
selection that are to be considered for procurement and clinical trials in accordance with the national
regulatory processes.

The third chapter is on Procurement and Financing which discusses the three phases of the vaccine
procurement process, the resources and funding requirements for the vaccination program and the
measures placed in ensuring that the government funds are allocated and provided to entities with
vaccines that are proven safe and with efficacy.

The fourth chapter is the Shipment and Storage which provides the technical details on the adequate
supply chain system for the COVID-19 vaccination program which includes the proposed
distribution process flow and distribution scenarios based on the vaccine specifications, the cold
chain management, and details on the ancillary immunization supplies.

The fifth chapter is on Distribution and Deployment and discusses the principles that will guide the
distribution and deployment of COVID-19 vaccines, its corresponding strategies and the
identification of the segments of the population that are considered eligible for vaccination.

The sixth chapter provides a discussion on the Implementation of a Nationwide Vaccination. This
section provides a detailed explanation on the three phase approach, namely the i) Pre-
implementation Phase, ii) Implementation Phase, and iii) Post-Implementation Phase of the
national government in operationalizing the COVID-19 vaccination program.
The final chapter is on Assessment, Evaluation and Monitoring which discusses the post-
implementation phase events where it describes in details the vaccines safety monitoring, the
management of adverse events following immunization, the protocols for safety surveillance and
responses, and the mechanism for appropriate reporting, monitoring and evaluation of the COVID-
19 vaccination program.

Overall, this plan has been developed with input from experts of various government agencies
wherein central to its crafting is the objective of providing the operational guidance in the
implementation of the COVID-19 vaccine deployment and vaccination program in the Philippines.

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Introduction
Background

On 30 January 2020, the World Health Organization (WHO) declared Coronavirus Disease 2019
(COVID-19) as a Public Health Emergency of International Concern (PHEIC). On the same date,
the Philippines, an archipelagic country in Southeast Asia with a population of 109,581,078 (based
on the 2020 Philippine Statistics Authority census), had its first laboratory-confirmed case of
COVID-19. COVID-19 is a disease caused by a novel coronavirus first reported from Wuhan,
China last 31 December 2019, and was later named as the Severe Acute Respiratory Syndrome-
Coronavirus 2 (SARS-CoV-2). On 7 March 2020, the Department of Health (DOH) announced
the country’s first reported local transmission when a 60-year-old male, without any travel history
outside the Philippines was confirmed to be positive for SARS-CoV-2. On 11 March 2020, the
WHO characterized COVID-19 as a pandemic.

Since then, the Philippines has been responding to mitigate the impact of COVID-19 pandemic
and has been implementing numerous interventions with varying levels and degrees of success.
These interventions are anchored on the National Action Plan Against COVID-19 (NAP), the
national strategic plan for COVID-19 pandemic response, and utilized the Prevent-Detect-
Isolate/Quarantine-Treat-Reintegrate (PDITR) strategy. For NAP Phase I (March-June 2020), the
National Government focused on preventing and containing the COVID-19 pandemic while
mitigating its socioeconomic impact. For NAP Phase II (July-September 2020), the National
Government focused on socioeconomic recovery. Lastly, for NAP Phase III (October 2020-March
2021), the National Government focused on managing the health risk while gradually transitioning
to full socioeconomic recovery, and inclusion of vaccines as part of the COVID-19 interventions.

Vaccines have saved millions of lives in the past. Countries around the world have implemented
numerous immunization programs against more than 20 life-threatening diseases, such as measles,
poliomyelitis, hepatitis B, influenza, and many others. These vaccination efforts prevented almost 2-
3 million deaths every year and allowed people to live longer and healthier lives. Also, through
vaccination, eradication and near elimination of diseases have been made possible, such as in the case
of smallpox and poliomyelitis.

In the past, vaccines have also been utilized as an integral part of epidemic (pandemic) response to
infectious diseases. Examples are the 2009 Influenza pandemic vaccines against the novel influenza
A (H1N1) virus and the Recombinant Vesicular Stomatitis virus–Zaire Ebola virus (rVSV-ZEBOV)
vaccine against Ebola in 2014 to 2016. Such vaccines have prevented succeeding outbreaks and
further disease spread, and have aided in saving thousands of lives. An exemplar of the benefit of
vaccines in halting disease outbreaks and breaking the chain of transmission was in August 2018

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when the Democratic Republic of Congo (DRC) declared the Kivu Ebola epidemic as 53
individuals were infected and 29 deaths were reported, 300,000 individuals were vaccinated
immediately thereafter. This endeavor resulted in halting the outbreak within the region, and due to
continuous efforts via the ring vaccination strategy, the reported number of deaths among those who
were infected and infected cases of tertiary contacts (contacts of contacts) were significantly reduced.

Thus, with the COVID-19 pandemic, the Philippines is exploring all means to access COVID-19
vaccines and prepare the country for the implementation of a COVID-19 deployment and
vaccination program once a safe, effective and good quality vaccine is readily available.

Rationale for the National Deployment and Vaccination Plan

The Philippine National Deployment and Vaccination Plan for COVID-19 Vaccines was drafted
for the purpose of providing operational guidance in the implementation of the COVID-19 vaccine
deployment and vaccination program.

The drafting of the plan involved the participation of various government agencies to ensure
alignment of policies and plans among agencies and integration of the said plans into national
governance mechanisms.

In addition, the deployment of COVID-19 vaccines and the implementation of the COVID-19
vaccine program necessitates the participation of all members of the society. Thus, a whole-of-
society approach is being implemented where all members of the society and government are
encouraged to participate and take action to achieve collective goals and objectives. In this regard,
while the government leads in the deployment of vaccines and implementation of a vaccination
program, the private sector and other organizations are engaged to collaborate and work closely with
the government to ensure a unified and coordinated vaccination campaign is conducted.

Target Audience

The target audience for the Philippine National Deployment and Vaccination Plan for COVID-19
vaccines include but are not limited to:
● Policy makers
● Planners
● Program and project implementers
● Development partners
● Health service providers
● Partners in public and private sector
● Civil Society Organizations

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 ● Health consumers and the general public.

Dissemination of the Plan

Providing this Plan to the different audiences in a meaningful way that will engage the audience and
enable action will require that there are different versions and formats of this plan. The visual below
summarizes the proposed dissemination of the plan.

Users Needs Dissemination

● Government at all levels ● Taking stock Contents (what)

● Development partners
● International agencies
● Private Sector
● Academic and Research
Institutions
● General Public
● Any changes / updates ● Tables
in the plan ● Graphs and maps
● Follow-up ● Analysis
● Planning and ● Policy briefs and briefers
Projections ● Powerpoint presentations
● Sector analysis Media (How)
● Buy-in ● hard copy of the plan
● Soft copy of the plan
● media (TV, newspapers)
● workshops and seminars
● government’s knowledge
management website.

Implementers at all levels should bear in mind the science, scale, skills, speed and systems needed for
proper, effective and seamless execution of this plan.

Guiding Principles

The development of the Philippine National Deployment and Vaccination Plan for COVID-19
vaccines is guided by the following principles:

A. National Ownership
The Philippine Government recognizes the huge national endeavor that the country needs
to undertake to ensure equal access to vaccines and to implement quality vaccination
services; the complexity of the vaccine deployment and vaccination activities; and the
necessity to protect national interests while ensuring that rigorous scientific review has been
undertaken prior to deployment and considering population safety. Thus, the national
government shall be the primary responsible entity to ensure good governance in the
implementation of vaccination services and provision of quality and effective immunization

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 services for all.

B. Shared Responsibility
The COVID-19 vaccine deployment and vaccination program is an endeavor necessitating
the participation of all members of the society where each member has a vital responsibility
to uphold and role to play. The Filipino Citizen, the communities, the national government
and the private sector have intertwined responsibilities in which when rightfully upholded
can positively dictate the success of the COVID-19 vaccination efforts of the country.

A whole-of-society approach shall be applied where all members of the society and
government are encouraged to participate and take action to achieve collective goals and
objectives. In this regard, while the government leads in the deployment of vaccines and
implementation of a vaccination program, the private sector and other organizations are
encouraged to collaborate and work closely with the government to ensure a unified and
coordinated vaccination campaign is conducted.

C. Integration
With the COVID-19 pandemic, vaccination against COVID-19 is provided to Filipino
citizens as an intervention and as an integral part of the national government’s pandemic
response. However, the COVID-19 vaccination services shall be fully integrated into the
country’s health systems and eventually to the regular immunization services.

D. Innovation
There has been a tremendous abundance of innovations and breakthroughs in the
development of COVID-19 vaccines. Developers and regulatory experts have collaborated
early on to help speed up vaccine development by ensuring that standards of safety and
efficacy are integrated in the process of development. In this regard, the Philippine
government recognizes the vitality of adapting newer knowledge and scientific evidence
gathered through research and innovation on COVID-19 vaccine and immunization to
ensure effective implementation of COVID-19 immunization services.

The allocation and prioritization of COVID-19 immunization shall be anchored to the following
principles:
A. Human well-being: where health, social and economic security, human rights and civil
liberties of all citizens and individuals are protected and promoted.
B. Equal respect: where all human beings are treated equally and their interests are considered
with equal moral consideration.
C. National equity: where equity in vaccine access is assured nationally and those with greater
burden of COVID-19 pandemic.

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 D. Reciprocity: where individuals and groups who bore a greater burden in the COVID-19
pandemic response and have higher significant risks brought by their responsibilities and
roles shall be given greater priority.
E. Legitimacy: where decisions are made through transparent processes based on shared values
and scientific evidence.

Process for Developing the Plan

The development process for this Plan was participatory and involved various stakeholders led by
the COVID-19 Vaccine Cluster and its Task Group (TG) and Sub-Task Group (STG) members.
These TGs and STGs were composed of various Departments and Agencies as outlined in the
section of Governance. The TGs and STGs under the COVID-19 Vaccine Cluster developed briefs
to guide the implementation of the vaccine. Key Informant Interviews were also conducted to
understand various perspectives in addition to various rapid assessments. A short-term technical
assistance staff was hired to collate the briefs/guides developed by each of the TGs and STGs. A
series of meetings were held to review and enrich the plan. The final draft of the plan was presented
to the DOH Executive Committee, COVID-19 Vaccine Cluster of the National Task Force for
endorsement. This is a living plan and will be updated as more information becomes available or as
recommendations are provided by WHO and Unicef.

Lay-out of the Plan

This Plan is set out in two sections: Special Chapters and Main Chapters.
The Special Chapters details cross-cutting interventions which covers:
● Governance
● Risk Communication and Community Engagement
● Registry and Data Management.

The Main Chapters cover the 7 stages of the Vaccine Roadmap:

● Scientific Evaluation and Selection of the Vaccine
● Access and Acquisition
● Procurement and Financing
● Shipment and Storage
● Distribution and Deployment
● Implementation of Nationwide Vaccination
● Assessment, Evaluation, and Monitoring

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Special Chapter
Governance

COVID-19 vaccine deployment and vaccination program is a combined national, regional, and local
responsibility that requires close collaboration between public health, external agencies, and
community partners. It is imperative that national and local agencies, public and private sectors, and
other planning partners clearly understand each other’s roles and responsibilities in the COVID-19
vaccination program. Therefore, a comprehensive and extensive organizational structure is critical
in the planning and execution of COVID-19 vaccine plans and policies; and essential for establishing
a robust system of leadership, accountable and transparent decision-making structure and process
to protect national interests. A wide array of expertise shall be represented among team members;
thus, a multi-sectoral organizational structure capable of making transparent and robust decision-
making and organizational processes is organized.

Using the guidance provided by the World Health Organization’s Vaccine Introduction Readiness
Assessment Tool (VIRAT), a multi-sectoral national organizational structure for the COVID-19
vaccine is established, institutionalized, and integrated with existing organizational structures and
coordination mechanisms for COVID-19 response. The VIRAT recommends creating the
following: a National Coordinating Committee, Technical Working Groups and Sub-Technical
Working Groups; and establishment and institutionalization of the National Immunization
Technical Advisory Group (NITAG) and National Adverse Events Following Immunization
Committee (NAEFIC), both are independent/external advisory bodies.

Therefore, the Philippine Government established the COVID-19 Vaccine Cluster Organizational
Structure. The COVID-19 Vaccine Cluster shall serve as an unified command, control,
coordination, communication, and cooperation mechanism that ensures the procurement,
deployment of COVID-19 vaccine and the vaccination of identified eligible populations (see Figure
1).

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Figure 1. COVID-19 Vaccine Cluster organizational structure.

Specifically, utilizing existing organizational structures and coordination mechanisms established for
the COVID-19 pandemic response, the organizational structure and line of command for COVID-
19 vaccines is as follows:

1. The Inter-Agency Task Force on Emerging Infectious Diseases (IATF-EID, or merely

the IATF) is a task force created through Executive Order No. 168 s. 2014 by the Philippine
President to respond to affairs concerning emerging infectious diseases in the country. For
COVID-19 vaccines, the IATF-EID shall serve as the National Coordinating Committee.

2. For the COVID-19 pandemic response, President Rodrigo Roa Duterte established the
National Task Force (NTF) Against COVID-19 to oversee the operations of the national
response. Detailing the strategic framework of the pandemic response, the National Task
Force drafted the National Action Plan Against COVID-19 (NAP) to guide the operations
of the pandemic response anchoring on the principle that the response should be national-
government-enabled, local government unit (LGU)-led, and people-centered.

3. Under the NTF Against COVID-19, there are three clusters namely, the Response Cluster,
the Recovery Cluster and the COVID-19 Vaccine Cluster. As mentioned above, seeing
the need for an organizational structure to support the strategic directions of the national
government, the COVID-19 Vaccine Cluster was added based on the guidance stipulated in
the NAP Phase III. In line with the directions of the VIRAT, the COVID-19 Vaccine
Cluster shall serve as the National Technical Working Group. The COVID-19 Vaccine
Cluster is led by Secretary Carlito G. Galvez, Jr., who was designated by President Rodrigo
Roa Duterte as the COVID-19 Vaccine Czar.

4. Under the COVID-19 Cluster are six Task Groups, and based on the direction of the
VIRAT, shall serve as the Sub-Technical Working Groups. Each TGs is represented by the

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 designated lead in the COVID-19 Vaccine Cluster Executive Committee. The Committee,
in turn, advises and updates the COVID-19 Vaccine Cluster Chair. The six Task Groups are
(see Figure 2):
a. Scientific Evaluation and Selection
b. Diplomatic Engagement and Negotiation
c. Procurement and Finance
d. Cold Chain and Logistics Management
e. Immunization Program
f. Demand Generation and Communications.

Figure 2. The COVID-19 Vaccine Cluster and its Task Groups.

The Task Groups are composed of various government agencies and participated by diverse
experts and professionals:
a. TG Scientific Evaluation and Selection
i. Lead: Department of Science and Technology (DOST)
ii. Members: Department of Health (DOH), Food and Drug Administration
(FDA), Research Institute for Tropical Medicine (RITM), Department of
Trade and Industry (DTI), Department of Foreign Affairs (DFA), National
Development Company (NDC), and the Vaccine Expert Panel (VEP)

iii. Roles and Responsibilities:

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 1. Provide oversight on the evaluation of applications and conduct of
COVID-19 vaccine clinical trials in the country.
2. Evaluate results of COVID-19 vaccine clinical trials as part of the
inputs on the criteria for COVID-19 vaccine selection.
3. Develop criteria and provide recommendations of the evaluation
and selection of COVID-19 vaccines that will be considered for
procurement.
4. Continue engagement with bilateral partners for clinical trials
interested in pursuing local manufacturing and technology transfer.
b. TG Diplomatic Engagement and Negotiation
i. Lead: Department of Foreign Affairs (DFA)
ii. Members: Department of Finance (DOF), DOH, National Task Force,
DOST, Office of the President (OP)
iii. Roles and Responsibilities:
1. Initiate diplomatic engagements with other governments,
international bodies, international non-government organizations,
international financial institutions, and international cooperation
agencies.
2. Provide feedback and updates to the other respective TGs pertaining
to vaccines in the global market.
3. Coordinate and collaborate with TG Procurement and Finance in
identifying viable global market vaccine manufacturers and entities.
4. Negotiate agreements for the provision of technical and financial
assistance.
c. TG Procurement and Finance
i. Lead: DOF
ii. Members: Department of Budget and Management (DBM), DOH
iii. Roles and Responsibilities:
1. Facilitate procurement through various mechanisms allowed under
existing laws, rules and regulations through bilateral, multilateral
and other financial modalities (e.g. COVAX Facility and etc.).
2. Activate price negotiation board subject to HTA’s cost-effective
price, if applicable.
3. Coordinate with legislators, as may be necessary on budget and co-
payment ceilings.
4. Explore local vaccine production and supply, if applicable.

d. TG Cold Chain and Logistics Management

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 i. Lead: DOH, Co-Lead: Task Group Resource Management and Logistics
(TGRML) under the Response Cluster
ii. Members: DBM; Department of Interior and Local Government (DILG),
specifically, the Philippine National Police (PNP); Department of National
Defense (DND), specifically the Armed Forces of the Philippines (AFP) and
the Office of Civil Defense (OCD), Department of Information and
Communications Technology (DICT), Department of Transportation
(DOTr), RITM, FDA, and DTI
iii. Roles and Responsibilities:
1. Map the potential port(s) of entry, points of storage (stores), and
fallback facilities in the country with their respective cold chain and
transportation/distribution capacity for vaccines and ancillary
products and assess dry storage and cold chain capacity at all levels.
2. Facilitate acceptance and inventory of vaccines and logistics.
3. Facilitate and ensure storage, distribution and delivery of vaccines
and logistics to target areas.
4. Monitor cold chain practices and ensure that vaccines are handled
and disposed correctly and properly.
5. Develop a distribution plan down to the local level; adapt needs of
vaccines, syringes and safety boxes to planning of stages or phases
according to vaccine availability.
6. Schedule transportation of vaccines and other supplies at all levels.
7. Implement monitoring systems for vaccine distribution and
conduct inventories using logistics information software integrated
into existing systems and technology development (barcodes,
electronic tracking, etc.).
8. Define indicators to evaluate the supply chain from the
international up to the service delivery points.
e. TG COVID-19 Immunization Program
i. Lead: DOH
ii. Members: DILG, DND, Office of the Chief Presidential Legal Counsel
(OCPLC), Bureau of Corrections (BuCor), Philippine Coast Guard
(PCG), Department of Social Welfare and Development (DSWD),
Department of Justice (DOJ), Department of Education (DepEd), AFP,
PNP, BJMP, DICT, FDA, Department of Labor and Employment
(DOLE)

iii. Roles and Responsibilities:

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 1. Plan and craft policies, guidelines and standard operating
procedures related to the COVID-19 vaccine deployment and
program implementation.
2. Estimate potential numbers of target populations that will be
prioritized for access to vaccines stratified by target group and
geographic location
3. Identify potential COVID-19 vaccine delivery strategies
4. Create a data information system for all vaccine recipients
5. Provide capacity building and trainings to implementers
6. Develop or adapt existing and implement AEFI/Post-marketing
surveillance and monitoring framework
7. Ensure or craft guidelines, procedures and tools for planning and
conducting vaccine pharmacovigilance activities
f. TG Demand Generation and Communications
i. Lead: Presidential Communications Operations Office (PCOO)
ii. Members: DOH, National Telecommunications Commission (NTC),
Philippine Information Agency (PIA), DILG
iii. Roles and Responsibilities:
1. Design a demand and risk communication plan.
2. Implement social mobilization and community engagement
activities.
3. Ensure social preparation of target population groups and
geographical areas prior to vaccination.

5. Under the TG COVID-19 Immunization Program, are four Sub-Task Groups (STGs),
namely: STG Planning, Policy & Technical Support, STG Program Implementation, STG
Registry, Data Management and Monitoring & Evaluation, and STG Safety Surveillance &
Response. The STGs are composed of (see Figure 3):
a. STG Planning, Policy & Technical Support
i. Lead: DOH [Disease Prevention and Control Bureau (DPCB)]
ii. Members: DOH [Epidemiology Bureau (EB), and Health Policy
Development and Planning Bureau (HPDPB)], OCPLC, DepEd, DILG
b. STG Program Implementation
i. Lead: DOH (DPCB)
ii. Members: DOH [Health Emergency Management Bureau (HEMB) and
Health Human Resource Development Bureau (HHRDB)], DILG (BFP,
PNP, BJMP), DSWD, DepEd, DND (AFP), DOJ (BuCor), DOTr (PCG)
c. STG Registry, Data Management & M&E

11
 i. Lead: DOH (EB)
ii.Members: DOH [Knowledge Management and Information Technology
Service (KMITS) and DPCB], DICT, DWSD, DepEd
d. STG Safety Surveillance & Response
i. Lead: FDA
ii. Members: DOH [EB, Field Implementation and Coordination Team
(FICT), DPCB, HEMB]

Figure 3. Sub-Task Groups under the TG COVID-19 Immunization Program.

6. The COVID-19 Vaccine Cluster is supported by several independent bodies. These are:
a. The National Immunization Technical Advisory Group (NITAG) for
COVID-19 Vaccines is a multidisciplinary group of national experts responsible
for providing independent, evidence-informed advice to policymakers and program
managers on immunization and vaccine policy issues. The Philippine NITAG was
organized and created through a Department Personnel Order as issued by the
Secretary of Health of the Republic of the Philippines. The NITAG shall serve as an
independent body that provides recommendations to the DOH and COVID-19
Vaccine Cluster, ensuring transparency, credibility, and technical soundness to the
decision-making process and contributes to building public confidence COVID-19
vaccination program.
b. The National Adverse Event Following Immunization Committee
(NAEFIC), comprises representatives from different medical societies and vaccine
experts. It reviews, analyzes, and comes up with causality assessment as the basis for
the Food and Drug Authority (FDA) action and appropriate DOH bureaus/offices

12
 on Adverse Events Following Immunization (AEFI) and Adverse Events of Special
Interest (AESI).
c. The Health Technology Assessment Council (HTAC), whose mandate is to
undertake technology appraisals by determining their clinical and economic values
in the Philippine healthcare system, with the aim to improve overall health outcomes
and ensure fairness, equity and sustainability of coverage for all Filipino citizens.

Coordination

A coordination mechanism shall be set in place to ensure sufficient communication and information
are shared between Task Groups, Sub-Task Groups, and independent bodies such as the NITAG,
NAEFIC and HTAC, and the Vaccine Expert Panel.

The Vaccine Expert Panel shall provide regular updates to the COVID-19 Vaccine Cluster Head,
HTAC, NITAG, and NAEFIC.

Complementation

The national organizational structure, the COVID-19 Vaccine Cluster, is complemented with the
activation of an Incident Command System (ICS), which is supported by an operations center, duly
named as the COVID-19 Vaccine Operations Center. The VOC shall be established and
operationalized at all levels, as follows:
1. National COVID-19 Vaccination Operations Center
2. Regional COVID-19 Vaccination Operations Centers
3. Local COVID-19 Vaccination Operations Centers

13
Figure 4. The COVID-19 Vaccination Operations Centers at all levels.

The National COVID-19 Vaccination Operations Center shall be headed by the COVID-19
Vaccine Cluster Chair, The Regional COVID-19 Vaccination Operations Center shall be led by the
Centers for Health Development with the participation of other government agencies and the
Regional Task Forces Against COVID-19. And lastly, the Local COVID-19 Vaccination
Operations Center shall be led by the Local Government Units. The Provincial Vaccination
Operations Center shall oversee the Municipal and City Vaccination Operations Center
(component cities). To avoid overlapping of functions and oversight, the COVID-19 Vaccination
Operations Centers shall be distinctly separated from the EOCs of the COVID-19 Response
Clusters which are headed by the Regional/Local Task Forces.

The COVID-19 Vaccination Operations Center shall compose of various teams, namely:

1. Planning, Campaign Management and Technical Team [DOH, DILG, DSWD,

DepEd, AFP (their counterparts in the regional and local levels)]
Roles and Responsibilities:
a. National VOC:
i. Develop and release guidelines, policies, bulletins and advisories relevant to
the vaccination campaign.
ii. Set-up the National Vaccination Operations Center (NVOC).
iii. Conduct orientations/training to program managers, stakeholders,
implementers and monitors.
iv. Monitor the implementation of the campaign.
v. Review preparedness plans of the Regional VOCs and provide
guidance/recommendations to Regional VOCs.

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 b. Regional VOC:
vi. Develop and release bulletins and advisories relevant to the vaccination
campaign.
vii. Set-up the Regional VOCs within their respective areas; and advocate for
the establishment of the Local VOCs.
viii. Roll-out the conduct orientations/training to program managers,
stakeholders, implementers and monitors.
ix. Conduct orientations/training to program managers, stakeholders,
implementers and monitors.
x. Monitor the implementation of the campaign.
xi. Review preparedness plans and provide guidance / recommendations to
implementers.
xii. Analyze and report data to the National VOC.
c. Local VOC:
xiii. Develop and release bulletins and advisories relevant to the vaccination
campaign.
xiv. Set-up the Local VOCs within their respective areas.
xv. Roll-out the conduct orientations and capacity building to program
managers, stakeholders, implementers and monitors.
xvi. Monitor the implementation of the campaign.
xvii. Review preparedness plans of barangays and provide
guidance/recommendations to implementers.
xviii. Analyze and report data to the Regional VOC.

2. Finance, Cold Chain and Logistics Team [OCD, DOH, AFP; (their counterparts in
the regional and local levels)]
Roles and Responsibilities:
a. National VOC:
i. Conduct inspection and ensure the quality of logistics to be delivered.
ii. Ensure timely delivery of vaccines, syringes, personal protective equipment
(PPEs) and other logistics to Centers for Health Development (CHDs) and
Ministry of Health - BARMM, and those that are delivered directly to
implementing units.
iii. Closely coordinate with CHDs to ensure availability of vaccines, vaccine
carriers for cold chain management, and other supplies.
iv. Manage inventory of vaccines, its storage and distribution.
v. Coordinate with regional offices and LGUs on the latest inventory of
logistics, supplies and its actual utilization.

15
 vi. Facilitate the budget for the campaign’s operations.
vii. Prepare sub-allotment upon receipt of the approved sub-allotment
guidelines and ensure downloading of budget to regions prior to the
campaign.
b. Regional VOC:
viii. Conduct inspection and ensure the quality of logistics to be delivered.
ix. Deliver vaccines, syringes, PPEs, and other logistics to Local Government
Units, and or if required to implementing units.
x. Closely coordinate with CHDs to ensure availability of vaccines, vaccine
carriers for cold chain management, and other supplies.
xi. Manage inventory of vaccines, its storage and distribution.
xii. Coordinate with LGUs and implementing units on the latest inventory of
logistics, supplies and its actual utilization.
xiii. Facilitate the budget for the campaign’s operations.
c. Local VOC:
xiv. Conduct inspection and ensure the quality of logistics to be delivered.
xv. Ensure timely delivery of vaccines, syringes, personal protective equipment
(PPEs) and other logistics from national or regional delivery hubs.
xvi. Deliver vaccines, syringes, PPEs, and other logistics to implementing units.
xvii. Closely coordinate with CHDs to ensure availability of vaccines, vaccine
carriers for cold chain management, and other supplies.
xviii. Manage inventory of vaccines, its storage and distribution.
xix. Coordinate with implementing units on the latest inventory of logistics,
supplies and its actual utilization.
xx. Facilitate the budget for the campaign’s operations.

3. Coordination Team [OCD, DOH, DILG; (their counterparts in the regional and
local levels)]
Roles and Responsibilities:
a. National VOC:
i. Coordinate and collaborate with other government agencies, response
partners and stakeholders.
ii. Coordinate immediate concerns to appropriate DOH and NGA offices and
bureaus.
iii. Assist the Finance and Logistics Team for concerns related to delivery and
distribution of logistics and supplies.
iv. Oversee and provide human resource support to the National EOC.

16
 b. Regional VOC:
i. Coordinate and collaborate with other government agencies, partners and
stakeholders at the regional level.
ii. Coordinate immediate concerns of LVOCs to the RVOCs. Coordinate
with regional government agencies and partners to provide assistance and
response, and address concerns raised.
iii. Assist the RVOC Finance, Cold Chain and Logistics Team for concerns
related to delivery and distribution of logistics and supplies.
iv. Oversee and provide human resource support to the RVOC.
c. Local VOC:
i. Coordinate and collaborate with barangays, health facilities, partners and
stakeholders.
ii. Coordinate immediate concerns of implementing units to the LVOCs.
Coordinate with partners to provide assistance and response, and address
concerns raised.
iii. Assist the LVOC Finance, Cold Chain and Logistics Team for concerns
related to delivery and distribution of logistics and supplies.
iv. Oversee and provide human resource support to the LVOC.

4. Vaccine Safety, Surveillance and Response Team [DOH, FDA, DILG; (their
counterparts in the regional and local levels)]
Roles and Responsibilities
a. National/Regional VOC:
i. Oversee the design and implementation of the AEFI/AESI surveillance
system.
ii. National to assist regions in the conduct of AEFI/AESI case investigation
and comprehensive data analysis.
iii. Generate National AEFI/AESI Surveillance Report and provide
information to N/R VOC.
iv. Provide technical assistance or training to develop/enhance capacity of
regional/local AEFI/AESI surveillance.
v. Facilitate the convening of the National/Regional AEFI Committee
meetings for causality assessment.
vi. Coordinate AEFI/AESI surveillance activities with all VOC levels.
vii. Maintain a database of all reported AEFIs/AESIs.
viii. Provide regular updates on COVID-19 vaccine surveillance to the N/R
VOC.

17
 b. Local VOC:
i. Implement AEFI/AESI surveillance activities.
ii. Lead in the conduct of AEFI/AESI case investigation and comprehensive
data analysis.
iii. Generate AEFI/AESI Surveillance report and provide information to Local
VOC, then submit to RVOC.
iv. Provide technical assistance or training to develop/enhance capacity of
regional/local AEFI/AESI surveillance.
v. Provide regular updates on COVID-19 vaccine surveillance to the N/R
VOC.

5. Communications, Advocacy and Partnership Team [PCOO, PIA, DOH (their

counterparts in the regional and local levels)]
Roles and Responsibilities
a. National/Regional VOC:
i. Develop a communication and community engagement plan,
advocacy/information materials, and/or other relevant communication
documents/materials.
ii. Capacitate Health Education and Promotion Officers, social mobilizers and
communicators.
iii. Issue press releases relevant to the COVID-19 vaccination campaign.
iv. Document COVID-19 vaccination campaign activities.
v. Monitor the implementation of communications and community
engagement activities in the LGUs.
vi. Provide feedback or report communications and community engagement
issues and concerns to NVOC.
b. Local VOC:
i. Advocate to and conduct partnership meetings with partners and
stakeholders such as but not limited to the Local Chief Executives, LGU
officials, medical societies, civil societies, religious sector, private physicians
and other stakeholders.
ii. Distribute advocacy/information materials, and/or other relevant
communication documents/materials.
iii. Document COVID-19 vaccination campaign activities.
iv. Monitor the implementation of communications and community
engagement activities in the implementing units and communities.
v. Provide feedback or report communications and community engagement
issues and concerns to LVOC.

18
Figure 5. The teams under the COVID-19 Vaccination Operations Center.

The National Government is enjoining all Regional Offices and Local Government Units to
establish the Vaccination Operations Center as soon as possible.

The implementing units such as government hospitals (both private and public), private clinics,
government agencies, rural health units) shall forward all concerns and reports to the
City/Municipal Health Offices. The City/Municipal Health Offices, in turn, are required to report
all concerns and updates to the VOC.

All reports and unsettled issues of a VOC shall be raised to the overseeing VOC. The overseeing
VOC, on the other hand, shall provide feedback and provide recommendation to the reporting
VOC.

Three months prior to the vaccination activity, the VOCs are required to conduct regular meetings
and to submit readiness assessments on a regular basis to the overseeing VOC. During the campaign
period (as determined by DOH), all VOCs are required to operate for 24 hours in a week, and to
submit daily bulletin detailing coverage, refusals and deferrals, and AEFIs and AESIs monitored.
The reporting mechanism will be expounded on Chapter 7. After the campaign period, all VOCs
are required to conduct a program implementation review and submit the final coverage report.

19
Figure 6. COVID-19 Vaccination Operations Center timeline.

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Special Chapter
Risk Communication and Community Engagement

When a vaccine is introduced, it is necessary to guarantee that the population will receive the
necessary information about its characteristics and benefits to boost confidence and generate
demand. Demand Generation is a communication and engagement process to enable, inform,
motivate and empower specific groups to access a health service and claim their right to do so 1.
Strategies to achieve this include advocacy, ongoing community engagement and trust-building,
active hesitancy prevention, regular national assessment of vaccine concerns, and crisis response
planning.

Table 1. Strategies and their definition.

Term Definition

Advocacy Building coalitions and communicating evidence to influence decision-makers,

stakeholders and relevant audiences to change law, policies and administrative
practices

Social Mobilization Uniting partners at national and community levels through dialogue, coalition
building and group activities to create an enabling environment for positive health
behaviors.

Social Change Enabling interpersonal communication and community dialogue to allow groups of
Communication individuals to engage in a participatory process to define their needs, demand their
rights and transform their social system.

Behavior Change Implementing interpersonal communication and mass/social media campaigns to

Communication change individual knowledge, attitudes, motivation, self-efficacy and behavior.

Capacity building and Training of program managers, health workers, community health workers and civil
motivation society organizations (CSOs) to enable them to implement and manage Demand
Generation activities and effectively link vaccination services to communities.

Strategic communications and public messaging will be critical to ensure maximum acceptance of
vaccines, requiring a saturation of messaging across the national and local media platforms. This
communication and messaging will target the different audience groups like opinion makers and
social communicators who can influence the uptake, health care providers in both public and private
sectors, and the vaccine's primary beneficiaries. Partnerships with the media are essential to ensure
their support in promoting these messages. The information campaign led by the PCOO, through

1
Definition was adopted from the WHO-UNICEF guide on Positioning Demand Generation in National EPI
Planning and Implementation Processes

21
the PIA, will include key messages on vaccine safety and efficacy and target key populations and
communities addressing vaccine hesitancy2. The campaign will be developed using human-centered
design, extensive public and stakeholder engagement, and research on message development and
delivery. The different agencies of the TG Demand Generation and Communications will work
collaboratively to ensure that consistent and accurate information is at the foundation of the
communications effort. The communication plan will also help inform the Filipino people about
the national strategy of delivering the COVID-19 vaccine faster while still safeguarding the national
standards for safety and effectiveness as with any other vaccine.

Identifying the right messages to promote vaccine confidence, countering misinformation, and
targeting outreach to vulnerable and at-risk populations will be necessary to achieve high coverage.
The members of the national task group will build on its existing relationships with key regional and
local government offices to effectively implement communication campaigns. The national task
group will also be working to develop innovative approaches to improve vaccine uptake among hard-
to-reach critical populations.

Initiate demand generation

Ensuring sustainable demand for vaccination is only possible when beneficiaries and communities
trust the safety and efficacy of vaccines and the quality and reliability of the vaccination services.
They also need to have the necessary information, access, and motivation to complete the
recommended vaccination schedule on time.

The COVID-19 vaccination demand promotion strategy embraces contextualized and targeted
evidence-informed approaches, including social and behavior change communication, political will
and advocacy, health workforce capacity development, social mobilization, and community
engagement activities. The strategy provides the why, what, when, and how of COVID-19
vaccination. In support of the key messages on the COVID-19 vaccination, the demand promotion
and communication strategy will also leverage an enhanced BIDA Solusyon campaign to emphasize
the continued need to practice essential preventive behaviors, to enforce minimum public health
standards, to address myths and misinformation, and to empower individuals.

Understand and act on drivers of vaccine acceptance and uptake

Ideally, before preparing any informational material, the population’s knowledge and perception of
the disease and vaccination should be evaluated so that information and education needs can be
determined and appropriate content prepared.

2
These messages target identified drivers of motivation as per the Increasing Vaccination Model by the WHO-
established group, measuring behavioral and social drivers of vaccination (BeSD)

22
The SAGE working group on vaccine hesitancy classified contributors to vaccine hesitancy into 3
main groups:3
● Complacency: Low perceived risk of vaccine-preventable diseases, and vaccination not
deemed necessary. Other life/health issues are a higher priority.
● Confidence: Low levels of trust in vaccines, in the delivery system, and in health
authorities.
● Convenience: Barriers related to geographic accessibility, availability, affordability, and
acceptability of services.

The IEC materials developed will address all three factors. In addition to IEC material for the general
public, materials for several different target populations, including physicians, vaccinators, and
journalists, will be developed.

An integrated demand approach supporting informed decision among citizens

participating in the vaccination program

a. Informed Consent

Obtaining informed consent for immunization is both an ethical and legal requirement in any
vaccination program. Consent derives from the principle of autonomy and forms an important part
of medical and public-health ethics, as well as international law. The importance of consent is that
it facilitates the freedom to make choices that reflect the individual’s own values, beliefs and life
experiences. The primary principle for informed consent described in the Guide to Professional
Conduct, states: “Patients must be given enough information, in a way that they can understand, to
enable them to exercise their right to make informed decisions about their care. Consent is not valid
if the patient has not been given enough information to make a decision.” While the context of a
public health immunization program differs from both primary and secondary care prescribing,
similar principles apply. For consent to be valid, it must be informed, understood and voluntary,
and the person consenting must have the capacity to make the decision. Special consideration must
be given to consent arrangements for those individuals who may lack capacity to give consent.
Informed consent must be preceded by disclosure of accurate, adequate and relevant information in
a manner that is comprehensible to the person about the nature, purpose, benefits and risks of
vaccination. The benefits of vaccination should address both benefit to the individual and to society
such as the potential for individual and herd immunity. Risks, both in terms of known risks e.g.
adverse side effects as well as the potential for unknown risks attaching to the vaccine, should be
communicated to the vaccine recipient. In the current situation, it will be important to make clear
to potential recipients of a COVID-19 vaccine that the duration of immunity conferred is currently

3
3C framework is adopted from the report of the SAGE working group on vaccine hesitancy.

23
unknown and may not be equally effective across all age-groups. The benefits and risks that are
disclosed will depend on what is known about them at the time consent is given. Knowledge about
the vaccines will continue to advance and it is important that the benefit/ risk ratio be continually
reviewed and updated in all information and consent material provided to potential recipients will
often change.

b. Building Confidence for the Vaccine

It must be acknowledged that people will have questions about the COVID-19 vaccine. Potential
recipients should be given an opportunity to ask questions and to discuss any fears they may have
around vaccination. This is particularly pertinent in the context of promoting vaccine confidence.
The Philippines is no different to other countries when it comes COVID-19 vaccination planning
and the myriad of challenges this presents. As the health system gets ready for the national effort to
vaccinate against COVID-19, public health and healthcare and clinical experts, policy makers, and
the public will benefit from lessons learned from planning and workshop exercises and examining
the experience of previous public health mass vaccination programs. This Plan has considered both
the expertise developed and the experience gained by Expert Groups, organizations and agencies
across the country and continent from pandemics and outbreaks that have affected the Philippines
in the past, including the 2009 H1N1 Pandemic, and have proactively applied these lessons learned
to COVID-19 vaccination planning.

c. Provision of Concise and Clear Information

The members of the national TG Demand Generation and Communications, will generate
information for patients, consistent with the available authorized product information. For each
vaccine, this will be written in plain language including all major dialects and English and will be
displayed prominently and be freely available at all vaccination sites. It will also be available online.
A copy of the regulatory, approved patient information leaflet will also be made available (paper or
electronic means). This will help to ensure that each person receiving a vaccine is giving informed
consent to receive a COVID-19 vaccination, and that they (or their parents or guardians) will be
provided with consent forms and sufficient information to allow an informed choice to be made.
This information will be provided in a way that is fully comprehensible, and will describe the nature,
purpose, benefits and risks of the vaccination and any measures to alleviate the symptoms arising
from aftereffects (e.g. paracetamol to relieve high temperature). All information surrounding the
vaccine development, testing limitations (if any), and administration held by the manufacturer and
regulatory authorities must be fairly represented in a balanced and summarized manner. To provide
valid consent, potential recipients, who might have a range of literacy and numeracy skills, should
understand the core message of the vaccine’s purpose, benefits and risks. This includes disclosing
that suspected adverse reactions might not be caused by the vaccine and that rare side effects may
not have been detected in clinical trials.

24
d. Providing Up to Date information

All information, education and communication materials (including posters, social media releases,
patient information leaflets) will be subject to change as new data emerges, and may include, but will
not be limited, to the following relevant information about the COVID-19 vaccines:
● Approval process related to the vaccine’s market authorization, including testing and
limitations of testing
● Licensing
● Any new component or technology that has not been licensed or used previously
● Post-marketing analysis by the relevant regulatory agencies
● Potential and known side effects and adverse reactions including that described in the
regulated package leaflet (issued by EMA)
● How and where to report side effects – a phone number will be included
● How to alleviate possible symptoms arising

Accurate and updated information should be accessible to the target eligible population, with an
available central information source (such as a designated telephone service) that can be easily
approached for additional concerns/queries. While all information provided will represent the state
of knowledge at that time, new information and emerging facts will be documented and
promulgated where appropriate and in a timely manner. It is strongly recommended that none of
the communication strategies to be undertaken will compare or provide recommendations between
vaccine variants (currently available or yet to be approved) in a way that may devalue/denigrate one
in favor of the other.

e. Continuous Engagement with the Regulatory Authority

The TG Demand Generation and Risk Communication will continually monitor data from the
regulatory authority (FDA) in relation to vaccine safety signals, as well as any data arising from public
health monitoring and surveillance activities. As stated elsewhere within this plan, the relevant
authorities will be carrying out formal post-monitoring surveillance on the use of the COVID 19
vaccines to identify any emerging issues including significant adverse, purported or coincidental
events. The TG Demand Generation and Risk Communication will also ensure that any necessary
information arising from this monitoring of the vaccines will be adequately and promptly
communicated. Healthcare Professional Communications will be issued by DOH/Dept for Human
Resource. Any emerging safety issues will be communicated to DOH, or escalated to National
Immunization Program (NIP), as appropriate.

25
Communication and engagement of the public

Since the start of the COVID-19 pandemic, consistent communication of the public health advice
to protect from COVID-19 has played a central role in the Government’s response to the pandemic,
earning wide public co-operation. Clear and transparent communication on all aspects of COVID-
19 vaccines, led by subject matter experts, to build public trust in vaccine safety and efficacy will be
a critical element to the success of the Philippines’ vaccination program. The approach will build on
the successful communication and engagement program delivered throughout the COVID-19
pandemic to date, ensuring the communications response to the vaccine program is integrated into
existing COVID-19 communications. The arrival of vaccines will not mean zero COVID-19.
Instead, the COVID-19 vaccine will be added to the existing public health toolkit. Aligned to this,
Government public health advice will expand to include the availability of a vaccine. As the vaccines
roll out across the country, it will remain important that we continue to work with the public health
advice which asks us to wash our hands, cough into our elbows, maintain 2m social distance and
wear face coverings where appropriate.

a. Communications Strategy

This strategy aims to position COVID-19 vaccines as an additional tool in the public health advice
to protect against COVID-19 and encourage universal vaccination. Communication around the
program will be informed by the following principles:
● Ongoing understanding of public sentiment regarding vaccine
● Open and transparent communication, to be led by the PCOO’s Philippine Information
Agency (PIA), and developed by public health and immunization experts
● Clear and consistent communication to encourage vaccine uptake
● Cross Government collaboration reinforcing the public health advice

Communication on COVID-19 public health advice, including the COVID-19 vaccination

program, will need to be agile as with our response to the pandemic to date this will involve regular
communications and updates via the different government platforms, including but not limited to,
the Office of the President, the PCOO, and the DOH. Once the vaccination program has
commenced, data on the vaccine uptake will be incorporated into the daily COVID-19 press release,
COVID-19 data hub, and current communication channels.

b. An Evidence Informed Approach

Since the early days of the COVID-19 pandemic, the different government agencies have actively
listened to the public. Understanding, reacting and responding to public sentiment have been core
elements of the COVID-19 campaign. As progress has been made in vaccine development, that work
has continued, and has informed every element of this Strategy. Key insights from work to date with
the public:

26
 ● Many people who doubt the vaccine are in a dilemma: they want the vaccine but are
cautious. People are concerned as to the speed of the development of the vaccines and want
to be reassured as to their safety and effectiveness.
● Overall, we must own the idea that science is never 100%; no guarantees; no cast iron
certitudes.
● We should be forthright and proportionate in what we say. People of different ages have
different understanding and expectations about what vaccines will bring in the short to
medium term.
● Communication on the vaccine must be led by medics coming from a perspective of
expertise, science and health advice.
● Whatever the unknowns are, they need to be stated and owned; only communicate when we
have the facts.
● We need language that anyone will understand - so that everyone feels welcomed into the
communication.

c. Key Elements

c.1 A Phased Approach

The communications and engagement strategy will have three main phases.
● The first phase (pre-roll out) will focus on preparing for the vaccine roll-out - this includes
speaking about the safety and regulatory processes that are in place in the Philippines and
across the world; engaging with people who have genuine hesitancies around the vaccine;
communicating the Government Plan from acquisition to prioritization to distribution; and
communicating about the results of the clinical trials when they are available.
● The second phase (deployment) will focus on the deployment of the COVID-19 vaccine
– this includes national and local communication from key champions (including medical
societies, allied healthcare workers, local chief executives, etc) encouraging the public to get
the vaccine, informing who will administer it and where, identifying people of trust, opinion
leaders to act as ambassadors for the vaccine. Active expert participants in the campaign will
come from the DOH and other collaborating agencies, ensuring clear and consistent
communications from a trusted source.
● The third phase (post-deployment) will focus on strategies for after the COVID-19
vaccine deployment (post-deployment) - this includes continuous monitoring and updates
for key stakeholders and the general public, and building a sense of community and
responsibility to ensure the sustained protection of communities and continued promotion
of preventive behaviors (eg. wearing a mask, social distancing, etc)

27
 c.2 Trusted Voices and Peer to Peer support

Healthcare workers are an important at-risk population group. They are also a recognized and
trusted source of information and influence. Nurses, in particular, are trusted sources of
information for the public. The national TG Demand Generation and Communications will
prepare targeted messaging and briefings for this important stakeholder group. One of the most
effective means of increasing uptake of the flu vaccine among healthcare workers (HCW) continues
to be peer-to-peer communication and support. The national TG Demand Generation and
Communications will identify and inform local champions on the importance of all HCWs
receiving the COVID-19 vaccine when it is available to them.

This approach will also be taken with the general public. The Regional and Local VOCs will be
supported to work with local print and broadcast media, as well as local stakeholders to inform their
communities and support uptake of vaccine in their community. It is recognized that uptake will be
influenced by a wide range of influencers, depending on demographics. The role of community
leaders, religious leaders, celebrities and other influencers, will be important in conveying the
message.

c.3 Audiences and Stakeholders

The COVID-19 vaccine program will touch every person, every healthcare worker, every household,
every family in the Philippines. This is a challenge in terms of scale and timing, but it also offers us
an enormous open door to build trust and confidence in this vaccination program, because, like
COVID-19 itself, the vaccine is something that everyone cares about and has been affected by. There
are challenges in the scale of the program, the need for sequencing how the vaccine is offered to
people in priority groups, and in providing assurance about safety and effectiveness. Pressures may
grow in the coming months in these areas of challenge, but with the benefit of a comprehensive
demand generation and communication plan, these challenges can be addressed.

c.4 Initial Key Messages

The vaccine communications and narrative has already begun. The first key messages are already
being communicated (for the pre-roll out phase) and these include the following themes for the
general public:
● Benefits of Vaccine Urgency and Deployment
● Prioritization and Timing
● Rigorous Development, Approval, and Monitoring
● Global Cooperation

These identified themes include the following supporting messages:

28
 ● The Philippines will only use a vaccine if it meets the required standards of safety and
effectiveness. All the recommended vaccines used in the country are licensed by the EMA
(European Medicines Agency), the US Food and Drug Authority as well as our FDA. The
vaccines will be subject to ongoing monitoring in the Philippines by the FDA. They are
licensed for use only when they have been shown to be both safe and effective.
● Due to the urgency posed by the pandemic, exceptional efforts are ongoing to develop
COVID-19 vaccines and make them available as soon as possible. Unprecedented levels of
scientific research and collaboration, investment and early and proactive engagement
between vaccine developers and regulators has helped speed up development and ensured
that quality, safety and effectiveness are not compromised.
● Vaccines are a proven, cost-effective intervention to protect public health; second only to
the provision of clean water. Worldwide, they save at least 2-3 million lives each year – and
many more from crippling and lifelong illnesses.
● Certain priority groups will be vaccinated first. For example, frontline healthcare workers
and people who are most at risk from serious infection if they catch COVID-19. Once these
priority groups have been vaccinated, the vaccine will be available to the rest of the
population.
● The vaccines will be delivered in stages so it will take time to vaccinate everyone. This means
we will need to continue to be careful about our individual actions to stop the spread of
COVID-19. For example, social distancing, wearing a face covering and regular hand
washing. We cannot afford to drop our guard now.

After the pre-rollout phase, the messages for the next phase (deployment phase) will address themes
focusing on 1) Patient responsibility and follow-through; and 2) Legitimate sources of vaccines and
reliable vaccination posts.

Then for the third and last phase (post-deployment phase), the messages will focus on 1)
Continuous monitoring and responsible reporting; and 2) Sense of community.

d. Promoting Vaccine Confidence

The vaccine confidence continuum includes a small minority who refuse all vaccines with
conviction, and those who have valid concerns and need more information before deciding to take
a vaccine as well as those who have a positive predisposition to vaccination programs. From the
October 2020 IDinsight survey commissioned by the DOH Health Promotion Bureau and
UNICEF, about half (52%) of the participants responded that they would get vaccines for
themselves if available. Effectiveness was the most frequently cited important piece of information
necessary for deciding whether to get a vaccine (40%), followed by side effects (18%) and safety risks
(17%).

29
As part of the approach to building confidence, the TG Demand Generation and Communications
will strategically address misinformation which may appear on social media and the internet, and
direct people to more credible sources of information such as the online platforms/websites of the
PCOO-PIA and the DOH. There is precedence for the introduction of novel vaccines in response
to significant health risks associated with certain diseases, for example, polio, meningitis and
haemophillus influenza B (HiB) vaccines as part of the childhood vaccination programme, and
pertussis vaccine in pregnancy.

After the Ebola outbreak of 2014-2016, researchers in Oxford University began preparing plans to
create a vaccine for any new emerging diseases that might afflict the world in the shortest possible
time. This body of work formed the basis of the Oxford AstraZeneca vaccine development process.
The Pfizer/BioNTech Phase 3 Clinical trials involved over 43,000 participants. Normally, clinical
trials can be held back due to low volunteer numbers and low disease prevalence – neither of which
have been an issue in the case of COVID-19.

While we await regulatory reports from the vaccine trials, government communication will
prioritize that proportion of the population that are unsure, addressing their questions and concerns
through clear and transparent evidence-based communication via a multitude of channels.

30
Special Chapter
Registry and Data Management

A robust and comprehensive data management system using information and communications
technologies, shall be established and utilized to monitor progress of vaccination activity, including
monitoring of vaccine safety and effectiveness. The data management system shall be used to:
1. Measure real-time and equitable uptake and coverage over time by geography and eligible
population groups.
2. Monitor implementation of the national vaccination program encompassing population
eligibility, supply chain logistics, and other important parameters.
3. Monitor vaccine safety, disease surveillance, and effectiveness.
4. Retrieve personal vaccination records or certification as deemed required.
5. Ensure data collection, consolidation, and analysis compliant with data privacy and security
standards.

I. Masterlisting during Pre-Implementation Phase

A nationwide profiling of eligible population shall be conducted prior to the implementation of the
vaccination activity and shall be utilized to determine the eligibility of the priority groups receiving
the vaccine.

To prepare the country for the COVID-19 vaccination program of the DOH, creation and
maintenance of a masterlist of priority sectors is necessary to: (a) provide basis for identification of
target eligible groups for vaccination and identification of priority areas for registration of eligible
individuals; (b) ensure uniqueness of individuals in the vaccine administration plan; and (c) provide
input to operational planning especially for costing and allocation of resources. Masterlisting shall
use the phased approach, and be initiated at the LGU level, specifically municipalities and cities, with
profiling and screening of eligible target population cohorts will be conducted prior to registration
into the electronic immunization registry. An informed consent is required before proceeding to the
registration.

The COVID-19 Electronic Immunization Registry (CEIR) shall be the official platform for
masterlisting and registration for COVID-19 vaccination. External systems may be used to submit
the necessary information following the Interim Minimum Required Data Fields based on DOH
standards and policies.

Local Government Units, specifically municipalities and cities, shall lead masterlisting, and
monitoring and evaluation within their catchment area, which shall be consolidated by province/
HUC/ ICC.

31
LGUs shall ensure that data provided in submission platforms are unique through deduplication of
linelists across facilities within their catchment. The DOH shall likewise conduct deduplication
checks on the final endorsed masterlists.

Consistent with actions necessary for Universal Health Care, LGUs should initiate profiling the
health status of their population and generate a masterlist of population with comorbidities and
other important information that will be necessary to implement the National Deployment and
Vaccination Plan. Health profiling through Electronic Medical Records consistent with DOH
standards is recommended.

II. Reporting and Data Management during Vaccination Date and for Adverse Events
Following Immunization (AEFI)

Municipalities/CC/HUC/ICC may utilize the CEIR or third party solutions that may link to the
CEIR, following set data standards. Reporting processes and data standards during actual vaccine
administration and monitoring for adverse events following immunization shall be released in
succeeding issuances. Ongoing simulation activities in select hospitals and LGUs shall inform these
standards.

In addition, registration of official members of the vaccination workforce (i.e., vaccinators) will be
conducted with data being recorded vis-à-vis the official vaccination sites/facilities as recorded in an
expanded version of the current National Health Facility Registry.

III. Overall Dashboard: Vaccination Information Management System

Pursuant to IATF Resolution No. 85, section B, item 8, the DICT shall lead and manage the design,
development, deployment, monitoring and evaluation of the Vaccine Information Management
System (VIMS). The VIMS shall serve as an electronic, confidential, and secure information system
that will record all vaccination doses administered by participating providers to people residing
within a given geopolitical area. It will be used to assess local vaccination coverage levels or to assist
during disease outbreaks, public health emergencies, or vaccine shortage situations to identify
individuals in need of vaccination. The VIMS shall be used to ensure vaccine management and
accountability, in tracking of vaccine safety issues, and in the evaluation of vaccine effectiveness.

The objectives of the VIMS will be as follows:

1. Provide visibility and control over vaccine stock balances and supplies beyond the
central stores (to correct overstocking and understocking);
2. Determine the status of our current cold chain capacity in near real-time;
3. Monitor temperatures in storage equipment to help identify underperforming
equipment or causes of (persistent) cold chain breaks
4. Determine vaccine consumption rates on a daily basis for purposes of forecasting and
distribution planning;

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 5. Determine, and potentially anticipate, if stockouts at the local government levels are a
problem; and
6. Determine how much vaccine ends up being wasted.

The following shall be the components of the VIMS:

1. Immunization registry
2. Logistics management
3. Stock management
4. Warehouse management
5. Supply chain management
6. Cold chain management

In order to successfully implement the VIMS, it shall follow a clearly defined governance model
using key global interoperability standards for a digital smart yellow card and leveraging a trusted
architecture to support roll out of the anticipated COVAX, and application to other routine
immunization systems.

The following will be the minimum required set of solutions:

1. A governance framework
2. A common enterprise architecture
3. Use of interoperability standards (i.e., HL7 FHIR) with a common taxonomy (i.e.,
SNOMED)
4. Defined certification specifications for secure issuance of certificates
5. Vetted digital solutions that incorporate all above items

Finally, the VIMS shall have the ability to issue a vaccination event certification, which shall be an
electronic form of the hard copy immunization card that the NIP issues to all vaccine recipients.

IV. Adoption of National Health Data Standards for Interoperability

The implementation of Universal Health Care Act recognizes the vital role of information and
communications technologies (ICTs) in the adoption of an integrated and comprehensive approach
to health development. Under Sections 31 and 36 of the Act, two of the key strategies identified are
to strengthen evidence-based sectoral policy and planning, and to improve the country’s health
information system (HIS).

To tangibly operationalize these strategies requires the use of common data standards to enable
seamless and interoperable health services and information flow operating under a functional
national health information infrastructure. The Department of Health shall regularly update
mandatory national health data standards for interoperability, enabled by establishing a core set of
terminologies, definitions, and structures for data and reports processing, sharing and exchange.

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V. Ensuring Data Privacy and Security

a. Consent of the Data Subject

Parties tasked to collect personal data should assure and undertake to obtain the consent of the data
subject and inform them of the following:
1. The identity of personal information controllers (PICs) and personal information
processors (PIPs) that will be given access to the personal data;
2. The purpose of data sharing;
3. The categories of personal data concerned;
4. Intended recipients or categories of recipients of the personal data;
5. Existence of the rights of data subjects, including the right to access and correction, and the
right to object. However, the other party shall be informed of any request to access or correct
personal information which is the subject matter of this sharing agreement; and
6. Other information that would sufficiently notify the data subject of the nature and extent
of data sharing and the manner of processing.

b. Procedures of Use or Process of Personal Data

Sharing and processing of personal data should be via a secure encrypted link, with a middleware
that shall have full control over such online access. Actual transfer of shared personal data or a copy
thereof from one party to another like in the form of emails or physical submission of printed copies
from one party to another may be done provided that processing and sharing must adhere to the
data privacy principles laid down in Republic Act No. 10173 (Data Privacy Act of 2012 [DPA]), its
Implementing Rules and Regulations, and other issuances of the National Privacy Commission
(NPC).

Recipients of the personal data shall likewise use appropriate safeguards to protect the personal data
from misuse and unauthorized access or disclosure, including maintaining adequate physical
controls and password protections for any server or system on which the personal data is stored,
ensuring that personal data is not stored on any mobile device (for example, a laptop or smartphone)
or transmitted electronically unless encrypted (using encryption standard prescribed by the National
Privacy Commission), and taking any other measures reasonably necessary to prevent any use or
disclosure of the personal data other than as allowed under this Agreement.

All identified personnel that have been authorized to receive, access and process shared personal data
shall sign a Non-Disclosure Agreement (NDA), specifically for the purpose of the national COVID
vaccination program.

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Chapter 1: Vaccine Selection and
Evaluation
There are 235 COVID-19 candidate vaccines under development as of 5 January 2021 based on the
WHO Draft landscape of COVID-19 candidate vaccines. Of these, 63 are under clinical
development with 15 candidates in Phase 3 clinical trials and 6 candidates in Phase 2/3 clinical trials.
To guide the choices on which vaccines will be considered for negotiation and procurement, the
VEP developed criteria for the technical evaluation of the candidate vaccines.

The VEP mandates are defined in the Philippine Council Health Research and Development
(PCHRD) Special Order No. 20-073 Series of 2020:
1. To identify and evaluate possible vaccine candidates from the local and international
partners of the DOST.
2. To identify local partners or institutions for the conduct of preclinical and clinical trials of
the vaccine candidates in the country.
3. To provide recommendations and action plans on the engagement of partners, preclinical
and clinical trials’ requirements of the FDA Philippines, DOH and WHO.
4. To evaluate project proposals on vaccine development seeking financial assistance from
PCHRD or DOST.
5. The mandate was expanded to evaluate applications for Emergency Use Authorization
(EUA).

Table 2. Criteria developed by the Vaccine Expert Panel for technical evaluation of COVID-19 Vaccines.

Criteria Weight

1. Track record of company in developing and/or manufacturing other vaccines 10%

2. Technology platform (reliability and stability related to storage requirement) 10%

3. Safety based on Phase 1 and 2 clinical trials 20%

4. Immunogenicity (potential efficacy based on Phase 2 clinical trials) 20%

5. Potential efficacy and safety based on published Phase 3 interim result and/or 30%
with Emergency Use Authorization

6. Vaccine implementation (i.e dosing schedule) 10%

TOTAL 100%

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The above-mentioned criteria adapt the WHO Criteria for COVID-19 Vaccine Prioritization and
WHO Target Product Profiles for COVID-19 Vaccines with additional criteria and considerations
suited for local needs. The two (2) guiding documents describe the preferred and minimally
acceptable profiles for human vaccines for long term protection of persons at high ongoing risk of
COVID-19 such as healthcare workers and for reactive use in outbreak settings with rapid onset of
immunity.

Considering that the Vaccine Roadmap will span three years with a target to start the vaccination of
eligible priority population by 2021, a prioritization mechanism was adopted by the Task Group on
Vaccine Evaluation and Selection to shortlist which vaccines will be initially considered for
evaluation:
1. Candidate vaccine is in advanced stage of clinical development, preferably in Phase III
clinical trial;
2. Vaccine developer is from a country with bilateral S&T partnership with the Philippines;
3. Vaccine developers expressed interest to conduct clinical trials in the Philippines and/or
engage in local manufacturing and/or technology transfer in the medium term.

Following the above-mentioned prioritization mechanism, the following vaccines were short-listed,
scored and weighted using the criteria developed by the Vaccine Expert Panel:

Table 3. COVID-19 vaccines shortlisted for VEP evaluation.

Vaccine Developer Technology Platform

Sinovac Inactivated

Sinopharma

Bharat Biotech

Anhui Zhifei Subunit

Novavax

Clover

Janssen Viral-vectored

Gamaleya

AstraZeneca

Pfizer mRNA

Moderna

Based on the overall scores, a ranking across platforms and ranking within platforms was endorsed
by the VEP to the Task Group on Vaccine Evaluation and Selection. This takes into account the

36
consideration that a vaccine per technology platform may need to be selected as it is expected that
there will be differences in vaccine characteristics depending on the type of technology platform
used, and a particular platform may be better suited to specific sectors or groups based on the results
of clinical trials.

The evaluation is subject to updating as more scientific data and evidence becomes available.
Further, as more candidate vaccines are expected to advance in late-stage clinical development, the
vaccines for consideration may be updated as there are still populations targeted for vaccination in
2022 and 2023.

The list of vaccine platforms, as ranked by the Task Group on Vaccine Evaluation and Selection will
advise the negotiations by the Vaccine Czar through the Task Group on Diplomatic Engagement
and Negotiation. Once an Agreement is reached, an Official Purchase Agreement will be affected
either thru bilateral or multilateral negotiations. To ensure safety and efficacy, it is to be clearly
understood that ONLY vaccines which are granted Emergency Use Authorization (EUA) or
Certificate of Product Registration (CPR) by the Philippine FDA will be purchased by the
government.

In the subsequent years of the Vaccine Roadmap implementation, as global supplies become stable,
and broad-base knowledge of vaccine efficacy and safety is established, the Department of Health
will develop a “Clinical Practice Guidelines (CPG) on the Use of Different Vaccines for Specific
Population Groups” in collaboration with professional societies and relevant stakeholders. The
vaccine selection will be based on this CPG, which will be further reviewed by the NITAG and the
Health Technology Assessment Council. The ultimate recommendation will be sought from
HTAC by the Department of Health before it procures from a portfolio of FDA-registered
COVID-19 vaccines, subject to the provisions of Republic Act 9184 or the Philippine Procurement
Reform Act.

37
Chapter 2: Diplomatic Negotiation and
Engagement
The Department of Foreign Affairs (DFA) oversees engagement with foreign governments,
pharmaceutical companies, and other relevant entities on vaccine development and evaluation and
selection of vaccines to be considered for procurement and clinical trials, with the view of assuring
that Filipinos will have access to COVID-19 vaccines.

The country apart from bilateral negotiations is also pursuing the multilateral track through the
COVID-19 Vaccines Global Access (COVAX) Facility that would ensure the country’s access to
COVID-19 vaccines for 20 million Filipinos.

Regulatory Preparedness

The COVID-19 vaccines may be accessed through: (1) conduct of clinical trial, and (2) emergency
use authorization (EUA) and eventually, market authorization. The Food and Drug Administration
(FDA), as the National Regulatory Authority (NRA), has the mandate on both as provided under
Republic Act No. 3720, or the “Food, Drug and Cosmetic Act,” as amended by Executive Order
No. 175, s. 1987, and Republic Act No. 9711, or the “Food and Drug Administration Act of 2009”.

A. Conduct of COVID-19 Vaccine Clinical Trials

Prior to the pandemic, the conduct of clinical trials in the country is regulated following FDA
Administrative Order No. 2020-0010, otherwise known as the “Regulations of the Conduct of
Clinical Trials for Investigational Products”.

In light of the COVID-19 pandemic, the Inter-Agency Task Force for the Management of
Emerging Infectious Diseases (IATF-EID) created the Sub-Technical Working Group on
Vaccine Development through its Resolution No. 39 dated May 22, 2020 to coordinate matters
pertaining to clinical trials of COVID-19 vaccine candidates. The Sub-TWG is chaired by the
Department of Science and Technology, co-chaired by the Department of Health, and with the
FDA, Research Institute of Tropical Medicine, Department of Foreign Affairs, Department of
Trade and Industry - Board of Investments, and the National Development Company as
member agencies.

The IATF-EID further supplemented the earlier resolution with its Resolution No. 65, s. of
2020, which requires that all applications for COVID-19 vaccine clinical trials should first be
submitted to the Vaccine Expert Panel (VEP) for technical review, to designated Ethics Board/s
(ERB/s) for ethical review, and once approved by the VEP and ERB/s, submitted to the Food

38
and Drug Administration for regulatory review and final approval. The Vaccine Expert Panel
(VEP) was created by the DOST to provide technical expertise on the evaluation of candidate
COVID-19 vaccine applications and to provide recommendations to the Task Group on
Vaccine Evaluation and Selection (then the sub-Technical Working Group on Vaccine
Development) on S&T activities on COVID-19 vaccine development. The regulatory process
of the FDA and the policies of the IATF-EID has been harmonized and streamlined under FDA
Circular No. 2020-029. The same Circular further expedites the evaluation for COVID-19
vaccine clinical trials application to a maximum of 40 working days, provided all requirements
are complete.

The functions of the Task Group, with the technical assistance from the VEP, has expanded
from providing oversight on the evaluation of applications and conduct of COVID-19 vaccine
trials in the country, to include as well the evaluation of COVID-19 vaccines that could be
considered by DOH in its selection of COVID-19 vaccines for the Philippines.

B. Emergency Use Authorization

In the Philippines, any new drug and vaccine should have an authorization from the FDA based
on an application containing full reports of investigations to show whether or not such vaccine
is safe, efficacious and of good quality for use based on clinical studies, prior to manufacture,
sale, importation, exportation, distribution or transfer thereof.

In light of the COVID-pandemic, the Philippines was declared under State of Public Health
Emergency, pursuant to Proclamation Nos. 922 (s. 2020) and 1021 (s.2020). Subsequently,
Republic Act No. 11494 or the “Bayanihan to Recover as One Act” was enacted authorizing the
President to suppress the COVID-19 pandemic through the procurement of drugs and vaccines.

Considering that there is no registered drug and vaccine yet for COVID-19 in the Philippines,
the President of the Republic of the Philippines issued Executive Order (EO) No. 121 entitled
“Granting Authority to the Director General of the Food and Drug Administration to Issue
Emergency Use Authorization (EUA) for COVID-19 Drugs and Vaccines, Prescribing
Conditions therefore and for other Purposes.” The said issuance gave authority to the Director
General of the FDA to issue an EUA, and establish the conditions under which said
authorization may be issued.

FDA Circular No. 2020-036 provides the process for the issuance of the EUA aimed to sustain
and strengthen the county’s preparedness and response for the COVID-19 public health
emergency. The principles of regulatory reliance and recognition are adopted to accelerate the
evaluation and approval process for EUA to ensure immediate access to drug products and
vaccines for COVID-19. The said circular defines that the EUA shall only be issued and remain
valid when all of the following circumstances are present:

39
 a. Based on the totality of evidence available, including data from adequate and well-
known controlled trials, it is reasonable to believe that the drug or vaccine may be
effective to prevent, diagnose, or treat COVID-19;
b. The known and potential benefits of the drug or vaccine, when used to diagnose,
prevent, treat COVID-19, outweigh the known and potential risks of the drug or
vaccine, if any; and
c. There is no adequate, approved and available alternative to the product for
diagnosing, preventing or treating COVID-19.

The last condition is deemed present when there exists no registered drug or vaccine in the
country for diagnosing, preventing or treating COVID-19. FDA Circular No. 2020-036
likewise provides other conditions for authorization on the distribution requirements, reporting
requirements, and safety and monitoring requirements.

Vaccines Access

Based on this guidance, a three-year vaccination roadmap was developed, where, in each year from
2021 to 2023, an identified eligible population will be given the vaccine. The vaccines will be sourced
from the COVAX Facility and from bilateral/multilateral sources [e.g. AstraZeneca, Sinovac, Pfizer,
Novavax, Johnson & Johnson, Gamaleya, Moderna, Sinopharm, CansinoBio (in no particular
order)].

The COVAX Facility, the vaccine pillar of the Access to COVID-19 Tools (ACT) Accelerator, is a
global risk-sharing mechanism for pooled procurement and equitable distribution of COVID-19
vaccines. The said facility will make investments across a broad portfolio of promising vaccine
candidates to make sure at-risk investment in manufacturing happens now. This means, by pooling
purchasing power from all countries that participate, the facility will have rapid access to doses of
safe and effective vaccines as soon as they receive regulatory approval. Guided by an allocation
framework being developed by WHO, the COVAX Facility will then equitably distribute these
doses to help protect the most at-risk groups in all participating countries. The COVAX Advance
Marketing Commitment (AMC), together with GAVI Alliance, will provide assistance and support
for the participation of 92 lower-middle and low-income economies, which includes the Philippines.

The selection of vaccines is based on the type of vaccine platform, track record of manufacturer for
developing or manufacturing vaccines for other diseases, safety based on Phase I and II clinical trial
results, potential immunogenicity based on Phase II clinical trials results, potential safety and
efficacy for those with interim Phase III clinical trial results, vaccine implementation (i.e. dosing
schedule), vaccine stability, and supply chain considerations. These criteria are weighted, and the
type of vaccines are subsequently ranked, and endorsed by the VEP to the Task Group on Vaccine
Evaluation and Selection.

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Table 4 below shows the yearly eligible population from 2021 to 2023, its proportion to the national
population.

Table 4. Target population for COVID-19 vaccination, its proportion to the national population.

Year 2021 2022 2023

Vaccine Access Eligible Population Eligible Population Eligible Population

Number Proportion to Number Proportion to Number Proportion

national national to national
population population population

PHL 110M 112M 114M

Population

Total Eligible 70M 63% 42M 37% 2M 2%

Population 70M 63% 112M 98%

112M 100% 114M 100%

Note: National Population Figures used: 2021 - 110,198,654; 2022 – 111,572,254; 2023 – 112,892,781. National
Population Figures were based on Population Projections by the Philippine Statistics Authority. Assumptions: By 2022, 16
years old and below can be vaccinated already and this sums to 42M Filipinos. By 2022, the total population of 15 years
old and above is 77 M. Those previously vaccinated shall be given booster dose the following years. By 2023, newborns shall
be vaccinated.

The COVAX facility will supply 20% of the total population of the country for free, while the other
bilateral/multilateral sources will be the source of vaccines to cover the rest of the eligible population
from 2021 to 2023.

41
Chapter 3: Procurement and Financing
The TG Procurement and Finance divides the process for procurement of vaccines into three phases.
The first phase involves preliminary meetings with said manufacturers and the signing of a reciprocal
Non-Disclosure Agreement (NDA). The NDA is put in place to protect the rights of both the
National Government and the manufacturer to their respective confidential information and allow
for smooth and transparent negotiations. Through the NDA, both parties agree on the type of
confidential information that may be disclosed to each other, the specific purpose for such
disclosure, exceptions to the right to confidentiality, as well as the rights of the parties and available
reliefs in case of breach. High level meetings facilitated by the TG Diplomatic Engagement are
likewise held.

During the second phase, the parties engage in formal negotiations, which normally commence with
the exchange of the term sheet. The term sheet ideally outlines all the relevant offers and details on
the vaccine procurement, including the number of doses to be ordered, the purchase price, the target
date of signing of the definitive and binding Supply Agreement, payment and effectivity dates,
delivery schedules, and all other rights and obligations of the parties. The term sheet is also reviewed
for possible implications under the procurement law as well as other applicable local laws. With the
goal of getting the best deal for the government, the TG Procurement and Finance would engage in
several rounds of negotiations with the supplier for possible revisions and/or clarifications of the
term sheet.

Matters that are resolved during the course of negotiations are documented, and pending matters
are likewise recorded for immediate consideration and resolution by the parties. Finally, negotiations
culminate in the signing by both parties of a Term Sheet, which although not yet binding, then
contains all the accepted offers and conditions for the supply of vaccines.

In the third and final phase, the National Government submits the Term Sheet to the financing
banks for clearance, and the parties finalize and sign the supply agreement in the form of either an
Advance Market Commitment, Supply Agreement or a Research & Development Investment.

The TG Procurement and Finance ensures that safeguards are well in place in the commercial
agreements to guarantee that government funds go to vaccines with proven safety and efficacy.
Thus, one of the integral terms negotiated by the team as a condition in the agreements is the
registration with the Philippine FDA through the Emergency Use Authorization before delivery,
and payment of balance. Among others, once the authorization is in place and in case of successful
delivery, the GoP stands ready to pay.

42
The financing for COVID-19 vaccine is made through the following modalities: (i) Using the
General Appropriations Act, (ii) Multilateral Financing, (iii) Bilateral Financing, and (iv)
Contractual Joint Venture (JV)/ Private Sector Financing. The first mode is carried out in
accordance with Republic Act No. 9184 or the “Government Procurement Reform Act” and
Republic Act No. 11494 or the Bayanihan to Recover as One Act (Bayanihan II). This amount will
partially cover logistics, distribution and monitoring costs. Procurement of COVID-19 goods,
supplies, and resources are exempt from the requirement of competitive bidding under Bayanihan
II, which has expired on December 13, 2020. Moreover, advance payment of 15% of the contract
price will be allowed in areas where a State of Calamity has been declared. Any advance payment
exceeding 15% of the contract price will have to be made under the directive of the President.

For procurement of vaccines and the Government’s contribution to the COVAX facility, the GoP
will tap financing with its multilateral development partners such as the ADB and the WB. The rules
governing procurement through multilateral loans are exempt from R.A. 9184 as this will be an
Official Development Assistance (ODA) loan. Nevertheless, the procurement rules of the WB or
the ADB, which are consistent with international standards, will apply.

To supplement the financing requirements under multilateral facilities with the ADB and the WB,
the government may consider co-financing from bilateral partners, such as China (Eximbank), the
UK (UKEF), the US, India, Singapore, and Australia, through tied-aid ODAs. Under this mode, the
executive agreement will apply when it comes to the procurement rules (limited source bidding).

Lastly, the funding for the vaccines covering the population that are not covered by the foregoing
may be through contractual joint venture (JV) agreements between the private sector, the
government, and a vaccine manufacturer/supplier. This may also be the route for procurement of
higher cost vaccines. With the private sector proponent initiating the process with its proposal,
negotiated procurement may be followed under the Revised NEDA Joint Venture (JV) Guidelines.
The procedure for a negotiated JV, and the approvals required depending on the terms of the JV
agreement shall be complied with. Ideally, the private sector and GOCC may share in the purchasing
process of the vaccine. Generally, no financing cost should be incurred by the Government,
however, there may be a need to evaluate the amount of user pay, which can require a subsidy from
either the private partner of the Government counterpart.

Resources and Funding

The WHO recommends allocating a budget for COVID-19 vaccination in multiple terms. The
short-term budget should consider the initial allocation that covers the first 3% of the national
population (health workers) and the next 17% of the population (older people and those with
underlying health conditions). The medium-term budget should consider the incremental
shipments to cover beyond the initial 20% (the additional priority populations). The 36-month

43
budgetary horizon is practical as it is compliant with ministry of finance (MoF) medium-term
budgetary and expenditure exercises.4

In addition to the cost of vaccines, other costs include those of the logistics needed to deploy the
vaccines (e.g. injection devices, PPEs), costs of hauling and storage, disposal of waste, program
operations, health promotion and communications and surveillance.

To fund the procurement of vaccines, several funding sources will be used. These include
multilateral and bilateral agreements, Domestic Government Financial Institutions (GFIs) and
bilateral negotiations. To procure the logistics needed for the deployment of vaccines, the 2021
General Appropriations Act (GAA) will be used. Table 5 below shows the different funding sources
and prospective amounts of funding.

Table 5. Funding sources for COVID-19 vaccine deployment program and corresponding funding amounts.

Object of Procurement Source Amount

Vaccines Unprogrammed Funds in 2021 GAA (Foreign ₱70 billion

multilateral and bilateral loans; domestic loans)

Logistics and other supplies 2021 GAA (DOH) ₱2.5 billion

Bayanihan II in relation to RA 11520 on ₱10 billion

Continuing Appropriations

TOTAL AVAILABLE FUNDS ₱82.5

billion

4
Guidance on developing a national deployment and vaccination plan for COVID-19 vaccines. Geneva: World
Health Organization; 2020 (WHO/2019-n-COV/NVDP/2020.1). License: CC BY-NC-SA 3.0 IGO.

44
Chapter 4: Shipment and Storage
Supply Chain

Successful immunization programs are built on functional, end-to-end supply chain and logistics
systems ensuring an effective vaccine storage, handling, and stock management; rigorous
temperature control in the cold chain; and maintenance of adequate logistics management
information systems. The ultimate goal is to ensure the uninterrupted availability of quality vaccines
from manufacturer to service-delivery points, so that opportunities to vaccinate are not missed
because vaccines are unavailable. Managing the supply, storage and distribution of potentially
multiple COVID-19 vaccines will involve complex logistical operations. In line with other countries,
the Philippines will leverage and build on existing vaccination delivery services and structures for the
rollout of COVID-19 vaccination plans.

Supply Chain Systems Readiness

To adequately prepare the existing supply chain systems to cope with the additional work required
to receive and distribute the COVID-19 vaccines, a rapid assessment of the existing supply chain
systems was conducted. The introduction of a new vaccine offers the opportunity to improve the
current distribution mechanism.

The assessment identified strengths and gaps in the End-to-End supply chain system including but
not limited to storage systems, distribution, real time temperature monitoring and tracking, real-
time tracing and reporting of vaccine stocks. The action plan based on the assessment will ensure
that:
1. There are coordinated deployment plans and standard operating procedures (SOPs) are
developed and communicated to all levels of the supply chain;
2. There are adequately trained, and sufficient quantity of supply chain and health staff;
3. There is sufficient cold chain capacity, including surge capacity, and capacity for
ongoing maintenance, necessitating the contracting of private providers;
4. There is an efficient supply chain system and infrastructure, preferably leveraging on
existing systems;
5. There is a real time robust data recording and reporting mechanism for vaccines and cold
chain equipment;
6. There is robust oversight and data-driven management, including systems for
monitoring adherence to cold chain practices; and
7. There are adequate secured resources from both internal and external sources.

45
End-to-End Supply Chain

While the specific logistics associated with each potential vaccine are not yet fully known, each
vaccine will broadly follow a similar supply chain to reach the vaccination locations as outlined in
the process below. Additional supply chain and logistics expertise across the wider public sector and
the private sector will be leveraged where necessary. The supply chain process will involve the receipt
of vaccines in the Philippines from several manufacturers, the storage of these vaccines in a
temperature controlled central storage facility, preparation of vaccines for distribution to
vaccination locations and the delivery logistics to vaccination locations. Figure X below highlights
the five components of the Supply Chain Management.

Figure 7. Five components of the Supply Chain Management.

Supply from Manufacturers

The arrangements for supply of potentially approved vaccines from pharmaceutical companies as
well as from the GAVI COVAX facility and the timing of delivery to the Philippines are currently
under discussion. It is expected that the volume of vaccines delivered will ramp-up through 2021 as
production capacity increases. Shipping methods from manufacturing sites will mainly be by air and
agreed upon with manufacturers. Supply Chain risks associated with natural disasters and
emergencies will be included in contingency planning.

Proposed Distribution Process Flow for COVID-19 Vaccines and Ancillary Immunization

The proposed process flow of the vaccines and other immunization supplies at the national level
from the notification of the delivery up to the reverse logistics for the final disposal of the
immunization wastes gathered from all the vaccination sites is summarized in the visual below.

The CHDs and the LGUs as well as those that will be identified as recipients of these immunization
commodities shall likewise develop their distribution plan appropriate to their situation. This shall
be consolidated by the Task Force to come-up with a comprehensive national cold chain and
logistics plan for COVID-19 vaccination.

46
Figure 8. Distribution process flow for COVID-19 vaccines and ancillary immunization supplies.

A detailed process in each category shall be presented. Existing relevant forms required for each
process shall be reviewed, revised and adopted specific for this purpose.

Cold Chain Management

COVID-19 vaccines require refrigeration with temperature ranges of +2ºC to +8ºC, -15ºC to -24ºC
and to as low as -70ºC to -80ºC; cold chain management, whereby adequate refrigeration levels are
maintained from manufacturing, storage and distribution of vaccines, and ensures integrity of
vaccine compounds via specialized packaging as well as refrigeration and freezer devices. However,
ensuring effective cold chain management for COVID-19 vaccines shall entail particular
requirements and constraints around temperature maintenance for transport and storage and
administration of the vaccines. With this, supply chain readiness at all the management levels shall
be in place to efficiently deploy COVID-19 vaccines to the target population.

STORAGE AND DISTRIBUTION OF COVID-19 VACCINES

Given the Philippine’s geographic size and population, storage of the vaccines will be centralized and
managed preferably by a single logistics provider, with substantial relevant experience.

As the different types of vaccine require varying temperature storage requirements, (1) ultra-cold (-
70°C to -80°C), (2) frozen (-15°C to -25°C), and (3) refrigerated (2°C to 8°C), the identified logistics
partner/s have to ensure substantial capacity for each temperature range.

To ensure the correct volume of vaccines are received by each Vaccination Administration Location
(VAL) at the right time, a robust, accurate, real-time inventory management system will be in place
to assure availability and maintenance of adequate supplies, minimize potential wastage and
accurately forecast demand which can be met. The varying storage temperatures and shelf-lives out

47
of storage of each vaccine type will mean certain vaccine types may be more suited to certain
vaccination location types, depending on the volume of vaccinations carried out at the setting and
the storage facilities on site. The distribution plan has accounted for this assigning the different
vaccines for different locations. Ensuring adequate availability of the vaccine for the second dose will
also be considered when managing stock levels.

To cater for the three (3) main temperature categories, namely: (1) +2°C to +8°C, (2) -20°C and (3)
-70°C to -80°C, a scenario based planning has been developed. The first two temperature ranges can
be handled in the current health structures because vaccines in the National Immunization Program
(NIP) has the same temperature requirement. However, the vaccines requiring -70°C to -80°C are
new and shall need a special storage package and a complicated distribution mechanism. Thus, the
following scenarios has been considered in the vaccine distribution:

Scenario 1 & 2: Distribution shall follow the pathway for the routine vaccines from the
national cold storage facilities up the service delivery points, the health centers and hospitals
allow the cold chain storage and distribution in NIP pathway of the current vaccines in the
National Immunization Program of the DOH. These vaccines require +2°C to +8°C cold
storage facilities. Such facilities are in place such as the Research Institute for Tropical
Medicine (RITM) as the centralized vaccine hub, regional warehouses and the RHUs and
hospitals.

Scenario 3 requires a cold storage facility of -70°C to -80°C. Currently, none of the
government hospitals are capable of such, thus the government will have to procure or
outsource/hire a private facility.

These scenarios may also vary based on the services that will be provided by the vaccine manufacturer
such as but not limited to direct distribution to the service delivery sites, presence of a distributor in
the country.

Within the Philippines, existing infrastructure and established vaccination distribution channels will
mean vaccines can be delivered efficiently using air and road distribution channels directly from the
central storage facility to the designated cluster hub warehouses. The logistics partner/s will also
manage the delivery fleet and outbound logistics / delivery to the principal vaccination locations. All
deliveries will be by chilled (+2°C to +8°C) distribution using the selected logistics partner’s fleet.
The fleet will operate to a very high specification with full GPS monitoring, remote temperature
monitoring and redundancy on the cooling systems on the vehicle. The vaccine handling
characteristics for other vaccines will be more clearly defined by manufacturers as the regulatory
approvals process emerges.

48
Assessment of Cold Chain Facilities and Dry Storage Capacities

The plan to introduce the vaccine includes the calculation of additional space requirements and cold
chain equipment at the national, and local levels, and even in the vaccination rooms. The data on
additional storage requirements are based on the dosage form and characteristics of the new vaccine
and those currently in use. and transport capacity for the vaccine at each level of the cold chain,
determining the need for additional equipment. This evaluation offers an ideal opportunity to
update the national cold chain inventory by type of equipment and operating condition. Both
public and privately managed cold storage facilities and logistics providers shall be assessed and
visited in partnership with the FDA.

Distribution of the Ancillary Immunization Supplies

Ancillary immunization supplies provided by the program shall include auto-disabled (AD) needles
and syringes, mixing syringes, safety collector boxes (SCB), PPEs (masks and face shields). The same
process as above shall be followed. The plan is all these items shall be delivered earlier than the
vaccines.

49
Chapter 5: Vaccine Distribution and
Deployment
Determining the Vaccine Recipients

Vaccination against SARS-CoV-2 offers the possibility of significantly reducing severe morbidity
and mortality and transmission when deployed alongside minimum public health standards and
improved clinical management of symptoms. However, even if safe and effective COVID-19
vaccines (most of which are still under various stages of development) will officially be authorized
for emergency use and eventually licensed by the FDA, these vaccines will not be immediately
available in amounts sufficient to vaccinate a large portion of the adult Filipino population. The
country’s COVID-19 vaccine deployment and vaccination program are largely dependent on the
global supply of vaccines available for the Philippines and the country’s ability to access them and
on the application of foreign manufacturers for EUA and Certificates of Product Registration
(CPR).

Equitable allocation of the COVID-19 vaccine is premised on current available evidence on

COVID-19 and its transmission, susceptibility to the disease, and risks of severe disease or death.
The current public health and clinical policies, recommendations need to be flexible and should be
updated as evidence emerges and realities change.

The identification of eligible populations was identified based on the WHO Strategic Advisory
Group of Experts on Immunization (SAGE) Values Framework for the Allocation and
Prioritization of COVID-19 Vaccination. In addition, the recommendations of the NITAG of
COVID-19 Vaccines shall guide the identification and finalization of the eligible population, taking
into consideration the national context, the epidemiologic settings and the COVID-19 vaccine
characteristics and supply.

The SAGE Values Framework provides the overarching goal and six core principles that should
guide the distribution of COVID-19 vaccines, of which, five (except global equity) were adopted by
the country. Thus, the identification of eligible population is guided by the following principles:

50
Table 6. Guiding principles adapted from the WHO SAGE Values Framework.

Principles

Public Good The COVID-19 vaccines shall be a main prevention commodity, and shall be made available
to all members of the society as public good, without prejudice to practice of public health
measures.

Human well-being Where health, social and economic, security, human rights and civil liberties of all citizens and
individuals are protected and promoted.

Reciprocity Where individuals and groups who have greater burden in the COVID-19 pandemic response
and have higher significant risks brought by their responsibilities and roles shall be given
greater priority.

Equal respect Where all human beings are treated equally and their interests are considered with equal moral
consideration.

National equity Where equity in vaccine access is assured nationally and those with greater burden of COVID-
19 pandemic.

Legitimacy Where decisions are made through transparent processes based on shared values and scientific
evidence.

The primary goal in identifying the eligible population and vaccination is to directly reduce
morbidity and mortality and maintain most critical essential services. The secondary goal is to
control transmission and minimize disruption of social economic and security functions. And lastly,
the tertiary goal is to resume the country’s essential activities to near normal. These goals guided the
selection of priority eligible groups. The selection of priority eligible group A fulfills the primary
goal, priority eligible group B addresses the secondary goal, and lastly, the priority eligible group C
addresses the tertiary goal.

Guided by these principles, the National Government drafted a decision matrix as stipulated in
DOH Administrative Order No. 2021-0005 entitled “National Strategic Policy Framework for
COVID-19 Vaccine Deployment and Immunization”.

51
Table 7. The Decision Matrix in determining priority eligible population groups.

Principles Objectives Population Groups

Human well-being ● Reduce deaths and ● Health workers

disease burden ● Older adults (senior citizens with or without
● Protect those in the comorbidities)
health services and ● Persons with comorbidities
essential services ● Personnel in government agencies providing essential
services (DSWD, DeEd, DILG, BJMP & Bureau of
Correction, PNP, AFP, PCG, BFP, CAFGU)
● Government workers, teachers and students, essential
workforce (agriculture, tourism, transportation, food
industry, tourism, manufacturing, construction, among
others)
● All workforce

Principles Objectives Population Groups

Reciprocity ● Protect those who bear ● Health workers (all)

significant additional ● Essential workers outside the health sector, those with
risks and burdens of high-risk of exposure, such as contact tracers, social
COVID-19 to workers providing social services, among others
safeguard the welfare of
others

Equal respect ● Treat the interest of all ● All citizens based on the availability of vaccines
individuals and groups
with equal
consideration as
allocation and priority
setting
● Vaccinate all citizens

National equity ● Ensure that vaccine ● People living in poverty (indigent population)
prioritization takes into ● Disadvantaged groups (PWD, PDLs, among others)
account vulnerabilities, ● Low-income workers
risks and needs groups ● Hard-to-reach areas
because of underlying ● Overseas Filipino Workers
societal, geographic or
biomedical factors

Thus, the Philippine National Government identified the following priority eligible population:

Table 8. The Priority Eligible Population.

Priorities Population Group Definition of Terms

Priority Eligible Group A*

1 Frontline Health Workers All health workers from the PRIVATE and PUBLIC sector
currently on ACTIVE practice/service, whether they are

52

employees or staff:
a) Public and private health
facilities [hospitals,
medical centers,
laboratories, infirmaries,
Treatment Rehabilitation
Centers (TRCs) and
Temporary Treatment
and Monitoring Facilities
(TTMFs)]
b) Public health workers (all All workers in the public health sector:
RHU/CHO personnel,
PHO, PDOHO, CHD
and CO) and LGU
contact tracers
permanent, contractual, job-order and/or outsourced
● All those are working in medical centers, hospitals,
clinics, laboratories, Temporary Treatment and
Monitoring Facilities (TTMFs), and Treatment
Rehabilitation Centers (TRCs). If the vaccine supply is
limited, priority shall be given to hospitals and medical
centers directly catering to COVID-19 patients,
including suspects, probable and confirmed COVID-
19 cases.
● Specifically, all those who are assigned in the triage
areas, out-patient departments, emergency rooms,
wards, intensive care units, operating rooms, delivery
rooms, laboratory, radiologic and pathology areas,
rehabilitation units, among others.
● Medical and allied health students who are serving as
clerks or interns in hospitals
● Those who are assigned as part of the disinfection or
decontamination teams, medical social workers, admin
personnel, and security guards of the above-mentioned
facilities.
● ALL employees in the public primary care facilities
(Rural Health Units, City Health Offices (whether
LGU-hired or DOH-hired/deployed)
● ALL health workers employed/deployed/detailed in
Provincial Health Offices, Center for Health
Development and Department of Health Central
Offices, including Food and Drug Administration and
Bureau of Quarantine
● ALL health workers employed/deployed/detailed in
DOH-attached agencies such as Philippine Health
Insurance Corporation, Philippine National AIDS
Council, Philippine Institute of Traditional
Alternative Health Care, Dangerous Drugs Board, and
National Nutrition Council
● LGU-deployed/designated/hired contact tracers
[those with appropriate documents stating
deployment/designation of government employees as
contact tracers either through an Executive Order
(EO), resolution and/or ordinance]
● Note: If the vaccine supply is limited, among workers
in public health, priority shall be given to those who
53

c) Barangay Health Workers
including Barangay Health
Emergency Response
Teams (BHERTs)
d) Other NGAs (DSWD,
DepEd, DILG, BJMP and
Bureau of Correction)
2 Indigent Senior Citizens
3 Remaining Senior Citizens
4 Remaining Indigent Population
5 Uniformed Personnel
are providing direct health services.
● ALL Barangay Health Workers in active service
● ALL active members of the BHERTs (based on
appropriate documents stating designation either
through an LGU EO, resolution and/or ordinance)
● DSWD, and its regional and local counterparts
○ All employees manning close-setting facilities
and long-term care facilities, e.g. orphanage,
home for the aged, women’s crisis centers.
○ Social workers providing social amelioration,
and social services in the communities
● DepEd
○ Health and nutrition personnel
● DILG
○ Those hired by DILG as contact tracers (active
service)
● BJMP (under DILG)
○ All employees and health workers assigned in
direct contact with Persons Deprived of
Liberty (PDLs) such as jail officers, wardens,
and/or guards
● BuCor (under DOJ)
○ All employees and health workers assigned in
direct contact with Persons Deprived of
Liberty (PDLs) such as jail officers, wardens,
and/or guards
ALL indigent senior citizens registered and as determined by
DSWD
ALL senior citizens (not categorized as indigent) registered
and as determined by DWSD
ALL indigent population as determined by DSWD
All enlisted uniformed personnel in active services under the:
● Armed Forces of the Philippines
● Philippine National Police
● Philippine Coast Guard
● Bureau of Fire Protection
● Citizen Armed Force Geographical Unit
54
Priority Eligible Group B**
6 Teachers and school workers
7 All government workers
(national and local government)
8 Essential workers
9 Socio-demographic groups at
significant higher risk other than
senior citizens and indigent
populations [e.g. Persons
Deprived of Liberty (PDLs),
Persons with Disabilities
(PWDs), Indigenous Peoples,
Filipinos living in high-density
areas)
Eligible Students
ALL teachers and school workers, whether permanent, job-
order, contractual or out-sourced in all educational levels,
from primary, secondary, tertiary, and vocational educational
institutions, both private and public
ALL government workers, whether permanent, job-order,
contractual or out-sourced, in national government agencies,
government-owned and controlled corporations (GOCCs),
government financial institutions (GFIs), local government
units, among others.
● All workers providing basic services during this time of
pandemic and essential to the growth of the economy as
determined by DTI and DOLE
● These workers may come from the following sectors:
agriculture, forestry and fisheries; transportation;
construction; food industries; manufacturing of
essential goods; tourism; essential retail; water-refilling
stations; laundry services; logistics service providers;
delivery and courier services; water supply and sanitation
services; telecommunication services; energy and power
companies; gasoline stations, among others
● All Persons Deprived of Liberty as determined by BJMP
and BuCor
● All Persons with Disability as determined by DSWD,
and National Council for Disability Affairs (NCDA)
and LGUs
● All Indigenous Peoples as determined by the National
Commission on Indigenous Peoples (NCIP). This may
include: the Lumads of Mindanao, the Peoples of the
Cordillera, and scattered tribal peoples of the hinterlands
of Central and Southern Luzon, Viasayas, Mindoro and
Palawan
● All Filipinos living in high-density areas as determined by
the LGUs (as documented in the LGU’s Comprehensive
Land Use Plan) such as in slums and temporary shelters,
among others; including those who are homeless and
living in temporary shelters and homes
● All students in primary, secondary and tertiary and
vocational educational institutions.
However, vaccination of students below 18 y.o. will
depend on the recommendations of WHO and NITAG,
55
 with the concurrence of the COVID-19 Vaccine
Cluster.

10 Overseas Filipino Workers Filipino migrant workers who reside in another country for a
(OFWs) limited period of employment that were not yet vaccinated

11 Other remaining workforce All remaining Filipino workforce as determined by the

DOLE, DTI and CSC

Priority Eligible Group C**

12 Remaining Filipino Citizens All Filipino Citizens that were not mentioned in priority A
and B

* Persons with co-morbidities are being taken into consideration as part of Priority Eligible Group A depending on the latest
development and scientific evidence. This is being discussed by the NITAG.
**The Priority Eligible Group B and C may change as these categories will still undergo review of the NITAG and final
approval of the COVID-19 Vaccine Cluster and the IATF.

Vaccine Deployment Strategies

The deployment of vaccines will be in a phased approach depending on the delivery (timing,
available doses, logistical requirements) of vaccines to the country. It will be executed based on a
sectoral approach - that is, all frontline healthcare workers will be vaccinated first before proceeding
to the next priority group. The number of individuals to be vaccinated in a round will depend on
the total number of vaccines delivered, in which computation of the 2nd dose is already considered.

Since the delivery of vaccines to the country is in tranches, the deployment of vaccines in specific
geographical areas shall be based on the burden of COVID-19 cases. In the identification of
geographical areas, the NITAG set the indicators in determining the areas with high burden of
COVID-19 cases. The indicators are as follows:
1. Number of Active Cases in recent four weeks
2. Attack rate per 100,000 in recent four weeks

Active cases refer to the total confirmed cases less those recovered and fatalities. These active cases as
such are assumed to be still infectious and currently isolated. For the purpose of this ranking, we
computed the attack rate using the total newly reported cases in the recent 4 weeks divided by the
region's projected population and a multiplier of 100,000 population.

The determination of priority geographical areas will be per region. Likewise, the NITAG will
review the burden of COVID-19 cases in the country every month and will recalibrate the priority
areas accordingly.

56
Table 9. Priority Regions based on burden of COVID-19 cases as of January 2021.
Population Density Rank
Region Total Cases Total Rank Number of Attack Rank Average Overall
(Population
As of Jan 8 Active (Active Cases Rate (Attack Rank Rank Density)

Cases as of Cases) Recent 4 (Recent 4 Rate) (Burden of (Burden of

Jan 6 Weeks (Dec Weeks) Disease) Disease)
6 - Jan 2)

NCR 27,104 7,181 1 10,978 80 2 1.5 1 22,301.54 1

Region 23,134 3,626 2 6,407 40 5 3.5 2,3,4 968.71 2

IV-A

Region 88,405 1,804 4 3,093 58 3 3.5 2,3,4 258.94 8

XI

CAR 212,876 976 6 2,289 127 1 3.5 2,3,4 91.22 17

Region 8,567 1,314 5 2,544 54 4 4.5 5 204.11 12

VIII

Region 2,885 2,144 3 3,771 31 8 5.5 6 562.12 3

III

Region 12,157 701 8 1,425 39 6 7 7 184.57 13

II

Region 5,472 751 7 1,684 21 10 8.5 8 380.15 6

VI

Region 6,131 834 9 1,241 25 9 9 9,10 245.24 9

X

CARAG 5,605 573 11 951 35 7 9 9,10 92.99 16

A

Region I 4,822 569 12 940 18 11 11.5 11 406.57 5

Region 2,853 646 10 952 12 14 12 12 513.77 4

VII

Region 32,575 499 13 800 16 12 12.5 13 215.92 11

XII

Region 13,810 342 14 606 16 13 13.5 14 228.21 10

IX

Region 5,194 309 15 525 9 16 15.5 15,16 338.62 7

V

Region 8,967 185 16 365 11 15 15.5 15,16 107.24 15

IV-B

BARM 6,010 126 17 194 5 17 17 17 114.14 14

M

As shown in Figure 8, in parallel with the preparations of the National Government in accessing
COVID-19 vaccines and in reviewing applications of vaccine manufacturers for EUA, the
National Government is also preparing for the COVID-19 vaccine deployment and
implementation of the vaccination program. As the National Government will roll-out policies
and plans, several activities in coordination with the Local Government Units will be conducted,
such as simulation activities, such as table activities and drills, to test local plans and

57
implementation of policies in the local level. The rest of the activities stipulated in Figure 8 will be
discuss in Chapter 6.

Figure 9. Vaccine Deployment and Service Delivery Activities.

Vaccine Distribution Strategies

The manner of the distribution of vaccines will depend on the storage requirements specific to each
vaccine. DOH will provide a Department Memorandum detailing the operational guidelines,
including the vaccine storage and cold chain requirements, delivery and deployment mechanisms
for each specific vaccine.

For vaccines requiring +2°C to +8°C storage, the vaccines will be delivered from the supplier to the
RITM, which will serve as the government Centralized Vaccine Hub. From RITM, the vaccines
will be passed on to the regional warehouses/hubs. The Centers for Health Development, in
coordination with logistics partners and other government agencies, shall deliver the vaccines to
Local Government Units. The LGUs will then allocate vaccines to implementing units such as
medical centers, hospitals, infirmaries, RHUs and CHOs, and private clinics, where the vaccine will
be administered to the eligible recipient. The distribution process for vaccines requiring -20°C
storage will utilize the same process used for vaccines requiring +2°C to +8°C storage.

In addition, for vaccines requiring -70°C to -80°C storage, the vaccines will be delivered from the
supplier to a private centralized vaccine hub. And through a private distributor, the vaccines will be
delivered to hospitals and medical centers with cold chain capacity to store the vaccines. Or the
vaccines can temporarily be stored in rented private warehouses before they are delivered to hospitals
and medical centers. Plans and arrangements will be carefully made for the vaccines to be distributed
to implementing units and the administration of the vaccine to the eligible recipient.

58
Figure 10. Distribution of vaccines according to storage facility requirements.

59
Chapter 6: Implementation of a
Nationwide Vaccination
The implementation of a nationwide COVID-19 vaccination program shall be in a phased approach
taking into consideration the quantity of vaccines delivered to the country, the cold chain
requirements, and burden of COVID-19 cases in geographical areas. Therefore, there shall be several
rounds of COVID-19 vaccination campaign conducted within the year.

The Local Government Units, as mandated in Republic Act 7160, otherwise known as the “Local
Government Code of 1991”, shall take the lead in the implementation of the COVID-19
vaccination program in accordance with the policies and guidelines set by the COVID-19 Vaccine
Cluster and DOH. Thus, participating agencies and the private sector are enjoined to closely
coordinate with the LGUs in which their health facilities are located.

On the other hand, the National Government and its regional counterparts, shall provide strategic
direction, and technical and logistical assistance; cascade policies and guidelines; and capacitate
implementers, among others.

Specifically, for each deployment of a specific type and quantity of COVID-19 vaccine, the DOH
shall provide a Department Memorandum detailing the specific operational guidelines applicable
for the specific vaccine.

Further, all vaccination activities, whether the COVID-19 vaccines to be administered have been
procured by the National Government, the private sector or the LGU, shall be closely coordinated
with DOH and shall follow DOH policies and guidelines. No vaccination activity shall be
conducted without the guidance and the knowledge of DOH.

The implementation of a nationwide COVID-19 vaccination program is divided into three phases,
namely: 1) the pre-implementation phase, where preparations for the actual vaccination activity are
carried out, 2) the implementation phase or the actual vaccine administration schedule, 3) the post-
implementation phase, where all activities and reports to conclude a certain round are completed.

Pre-implementation Phase

In the pre-implementation phase, the following activities enumerated are to be undertaken by

LGUs, specifically municipalities and cities:
1. Establishment of a VOC (see Special Chapter: Governance)
2. Masterlisting of Eligible Populations, Vaccination Workforce, Implementing Units and
Vaccination Sites/Posts

60
 3. Microplanning
4. Mapping of Vaccination Sites and Vaccination Workforce
5. Vaccines, Logistics and Cold Chain Inventory and Management
6. Capacity Building and Training
7. Advocacy, Community Engagement and Social Preparation (see Special Chapter: Risk
Communications and Community Engagement)
8. Preparation of Vaccination Sites/Posts
9. Monitoring and Supervision (see Chapter 7: Assessment, Monitoring and Evaluation)

In this section, numbers 2-6 and 8 shall be extensively discussed while other numbers are explained
intensively in other chapters of this Plan.

I. Masterlisting, Microplanning and Mapping (3Ms)

The 3Ms, namely, masterlisting of eligible population, vaccination workforce and implementing
units and vaccination posts/sites; microplanning; and mapping of vaccination workforce and
vaccination posts/sites are critical in the implementation of the COVID-19 vaccination program. In
the succeeding section, each of the Ms will be discussed in detail.

1. Masterlisting of eligible population, vaccination workforce and implementing

units and vaccination posts/sites

To prepare the country for the COVID-19 vaccination program, creation and maintenance of a
masterlist of priority sectors is necessary to: (a) provide basis for identification of target eligible
groups for vaccination and identification of priority areas for registration of eligible individuals; (b)
ensure uniqueness of individuals in the vaccine administration plan; and (c) provide input to
operational planning especially for costing and allocation of resources.

Masterlisting is the linelisting and registration of the population prior to vaccination. This could be
done through an online or offline platform developed by the DICT, and DOH’s KMITS and EB.
From the masterlist, eligible population for specific vaccines will be culled out and accessed by
appropriate regions or LGU for registration, scheduling, mapping-out on appropriate vaccination
sites and advisory.

61
 a. Phased Submission of LGU Masterlists

Masterlisting shall use the phased approach, as follows:

Table 10. Phases of masterlisting.
Group A Phase 1: Workers in Frontline Health Services
Phase 2: All Senior Citizens (Indicate if indigent)
Phase 3: Indigent Population
Phase 4: Uniformed Personnels (UPs)

Group B Phase 5: Other Frontline Workers and Special Populations

Group C Phase 6: Remaining Population

Targets for Masterlisting are as follows:

1. Submission of total numbers and masterlist of demographics for Group A sectors by
January 31, 2021.
a. Minimum demographic fields include complete name, birthdate, sex, address,
profession/position, and unique identifier.
b. Unique identifiers may include QR code, PhilHealth number, or Category ID such
as PRC ID for healthcare workers.
2. Completion of patient profile including health status and consent for Group A sectors,
especially Phase 1: Workers in Frontline Health Services, by February 15, 2021.
3. Completion of full masterlist for Group A and Group B sectors by March 31, 2021.
4. Completion of full masterlist of Group C by June 30, 2021.

Masterlisting efforts shall be initiated at the LGU level, with profiling and screening of eligible target
population cohorts will be conducted prior to registration into the electronic immunization registry.
Prioritization for workers in health facilities shall be according to selected health facilities, public or
private, such as COVID-19-designated hospitals, those with relatively higher number of admissions
past two months, all LGU hospitals; and risk-based categories for healthcare workers that may be
determined.

b. Interim Minimum Data Standards for the COVID-19 Electronic Immunization

Registry (CEIR)

The COVID-19 Electronic Immunization Registry (CEIR) shall be the official platform for
masterlisting and registration for COVID-19 vaccination. External systems may be used to submit
the necessary information following the Interim Minimum Required Data Fields as indicated below.

62
Table 11. Interim minimum required data fields for masterlisting.

Data Set Definition Type Format

1. Category Category of the Target Eligible Population String Dropdown

01 – Health Care Worker
02 – Senior Citizen
03 – Indigent
04 – Uniformed Personnel
05 – Essential Worker
06 – Other

2. CategoryID ID number depending on the category type String Freetext

For 01 – PRC number
02 – OSCA number
03 – Facility ID number
04 – PWD ID
05 – Other ID

3. PhilHealth ID PhilHealth ID Integer Freetext, 12

digits only

4. Last name Surname/Last Name String Freetext

First name First Name/Given name String Freetext

Middle Name Middle Name String Freetext

Suffix Suffix String Dropdown

5. Contact_no Contact Number (Mobile Number or Landline) Integer Freetext, 12

digits only

6. Full_address Unit/ Building/ House Number, Street Name, Purok, String Freetext
Zone

Province Name of province String PSGC,

Dropdown

MunCity Name of city or municipality String PSGC,

Dropdown

Barangay Name of barangay String PSGC,

Dropdown

7. Sex Sex String Dropdown

01 – Female
02 – Male

63
 03 – Not to disclose

8. Birth date Date of birth (mm/dd/yyyy) Date Date picker

9. Civil status Civil Status String Dropdown

01 – Single
02 – Married
03 – Widow/Widower
04 – Separated/Annulled
05 – Living with Partner

10. Employed Employment Status String Dropdown

01 – Government Employed
02 – Private Employed
03 – Self-employed
04 - Private practitioner
05 – Others

11. Profession 01 – Dental Hygienist

02 – Dental Technologist
03 – Dentist
04 – Medical Technologist
05 – Midwife
06 – Nurse
07 – Nutritionist-Dietician
08 – Occupational Therapist
09 – Optometrist
10 – Pharmacist
11 – Physical Therapist
12 – Physician
13 – Radiologic Technologist
14 – Respiratory Therapist
15 – X-ray Technologist
16 – Barangay Health Worker
17 – Maintenance Staff
18 – Administrative Staff
19 – Other Workers in Frontline Health Services
*Categories for other subgroups to be included in
succeeding versions; LGU may create sub categories not
listed here

Direct_covid Providing direct COVID care? Boolean Dropdown

01 – Yes
02 – None

12. Employer_name Name of employer String NHFR or

freetext

64
 Employer_LGU Province/ HUC/ ICC of employer String PSGC,
Dropdown

Employer_address Full address of employer String Freetext

Employer_contact Contact number of employer Integer Freetext,12

_no. digits only

13. Preg_status If female, pregnancy status Boolean Dropdown,

01- Pregnant conditional
02- Not Pregnant (if female
only)

14. W_allergy With Allergy Boolean Dropdown

01 – Yes
02 – None

Allergy Name of Allergy String Freetext,

01 – Drug conditional
02 – Food (if with
03 – Insect allergy only)
04 – Latex
05 – Mold
06 – Pet
07 – Pollen

15. W_comorbidities With Comorbidities Boolean Dropdown

01 – Yes
02 – None

Co- morbidity Name of Comorbidity String Dropdown

01 – Hypertension
02 – Heart disease
03 – Kidney disease
04 – Diabetes mellitus
05 – Bronchial Asthma
06 – Immunodeficiency state
07 – Cancer
08 – Others

16. covid_history Patient diagnosed with COVID-19 Boolean Dropdown

01 – Yes
02 – No

covid_date Date of first positive result / specimen collection Date Date picker
(mm/yyyy)

65
 covid_classification Classification of infection String Dropdown
01 – Asymptomatic
02 – Mild
03 – Moderate
04 – Severe
05 – Critical

17. Consent Provided electronic informed consent for data collection? String Dropdown
01 – Yes
02 – No
03 – Unknown

18. Consent_vacc Provided initial consent for vaccination? String Dropdown

01 – Yes
02 – No
03 – Unknown

c. Prescribed Processes for Masterlisting Intended Vaccinees

1. Local Government Units shall lead masterlisting efforts within their catchment area and
consolidate by municipality/CC/HUC/ICC.
2. All institutions (ex: health facilities) shall submit the masterslists to the
municipality/CC/HUC/ICC, through any of the following methods:
a. COVID-19 Electronic Immunization Registry (CEIR);
b. Information system of the LGU linked to the CEIR through an application program
interface (API);
c. Dataset consistent with prescribed formats for bulk uploading through the CEIR; or
d. Dataset consistent with prescribed formats for bulk uploading through the assistance of
DOH CHDs.
CEIR platform may be accessed through http://ceir.doh.gov.ph. Training videos and
submission templates may be retrieved from http://bit.ly/CEIRdocuments. Regional templates
with PSGC codes are also available in said link. For help desk and support please contact
covid19ceir@doh.gov.ph.
3. Masterlist data may be submitted and consolidated in phases, to include the following fields:
a. Patient List - 1, 4, 7, 8, 10, 12
b. Full Patient Demographics - 1, 2, 4, 5, 6, 7, 8, 9, 10, 11, 12
c. Full Patient Health Profile - 3, 13, 14, 15, 16, 17, 18
4. LGUs shall ensure that there will be no duplication in masterlists across facilities within their
catchment. The DOH shall likewise conduct deduplication checks on the final endorsed
masterlists.

66
 a. Masterlisting for Phase 1: Workers in Frontline Health Facilities shall be done based on the
location of their health facility of assignment.
b. For the eligible population with multiple affiliations (ex: health care worker in multiple
hospitals), they shall choose only one health facility as their intended site for vaccination.
5. Masterlisting of UPs and essential personnel shall be based on their command. Masterlisting of
the general population shall be based on the LGU where the vaccinee is residing in.
6. The province/HUC/ICC health office shall provide a status report and updated consolidation
masterlist to their respective CHD every Friday.
7. After completion of masterlisting in a health facility, the Chief of Hospital or Head of Facility
shall submit physically signed endorsement of all workers in the facility for phase 1 vaccination
to the respective local government unit copy-furnish the CHD. The endorsement should
indicate those who have and consented and who have not.
8. CHDs shall compile and store all signed and attested masterlists of all LGUs and health
facilities, and scan copies saved according to the following format: Region-Health facility
name, i.e., NCR-SAN LAZARO HOSPITAL. The document shall be saved in Portable
Document Format (PDF) and be uploaded to the bit.ly link provided for their respective
region.
9. Consistent with actions necessary for Universal Health Care, LGUs are instructed to initiate
profiling the health status of their population now and generate a masterlist of population
with comorbidities and other important information that will be necessary to implement the
National Deployment and Vaccination Plan. Health profiling through Electronic Medical
Records consistent with DOH standards is recommended.
10. Complete masterist including patient list, full demographics, and full health profile is required
prior to actual vaccine administration. Phased submissions shall guide local and national
planning of the vaccine deployment plan.

d. Masterlisting the Vaccination Workforce

LGUs shall develop masterlists of the vaccination workforce by Municipality/CC/HUC/ICC using

the following minimum data fields:

Table 12. Minimum data fields required for the masterlisting of the vaccination workforce.

Data Set Definition Type Format

heathfacility_name Name of health facility String NHFR or freetext

healthfaiclity_LGU Province/ HUC/ ICC of employer String PSGC, Dropdown

Last name Surname/Last Name String Freetext

67
 First name First Name/Given name String Freetext

Middle name Middle Name String Freetext

Suffix Suffix String Dropdown

Position Position or designation of the String Freetext

Team Team category String Dropdown

01 - Vaccination Team
02 - AEFI/ AESI Composite Team

Role Role in the vaccination team String Dropdown

01 - Screening and Assessment
02 - Health educator
03 - Vaccinator
04 - Documentor/ Recorder
05 - AEFI Monitoring
06 - Others

Local governments and CHDs shall determine the vaccination workforce and vaccination site/post,
compliant to standards set in the National Deployment and Vaccination Plan. Initial list of these
sites shall be submitted to the CHD by January 31, 2021.

2. Microplanning

Microplanning is a “bottom-up” planning process carried out to determine local needs and gaps and
to ensure smooth and satisfactory vaccine implementation. This is one of the key activities to ensure
the planning of the vaccination campaign lays out all operational aspects of the activity at the
municipal/city and barangay levels. It is the translation of the national and regional macroplan to
the local situation. Microplanning is one of the tools that health workers use and endorsed by the
NIP to ensure that immunization services reach every community.

The microplanning activity has been tailored fit for COVID-19 vaccines taking into consideration
diverse vaccine portfolios and the complexities of COVID-19 vaccine development.

The following are the objectives of microplanning:

1. To ensure that campaign objectives are reached and immunization strategies are well
implemented at the service delivery points (health facilities and LGUs).
2. To ensure that adequate resources are mobilized and in place with expected results to be
accomplished on time.
3. To anticipate the challenges and maximize use of limited resources in an efficient manner in
the context of the COVID-19 pandemic.

68
The microplanning shall be done by the LGUs, specifically by municipalities and cities, and shall
commence at once after masterlist and/or training has been obtained by the LGU.

It is paramount that microplans get validated at each level as data are collected. This calls for effective
supervision of the development of each microplan. Therefore, microplans are submitted in the
following order: for municipalities and component cities, to the Provincial Health Offices (PHO)
copy furnished Provincial DOH Offices (PDOHO), then the PHO to the CHDs; and for HUCs
and ICCs, directly to the CHDs.

Once microplans from C/MHO level reach the province, they get aggregated and the provincial
coordinators add province-specific costs (supervision, meetings, transport) are incorporated, before
forwarding the plan up to the regional and national level. The microplan must be updated as
frequently as possible.

A readiness assessment tool shall be used to assess and monitor the implementation of the plan. This
can also be https://tinyurl.com/covidvaccineRA or see Annex A. Also, a microplanning template
in excel form is accessible in this link: https://tinyurl.com/microplanningc19.

Here are the critical steps in microplanning:

Critical Step 1: Determine the number of eligible population for COVID-19 vaccination in
your area.

The number of eligible population can be culled out in the CEIR and shall be readily accessible to
LGUs. The DOH shall provide specific guidelines on who among the priority population shall be
vaccinated on a certain period of time depending on the vaccine supply and certain geographical
area.
a. Utilize data gathered during the masterlisting and profiling in determining the number of
eligible population for COVID-19 vaccination.
b. Once the type of vaccine to be deployed in your area is determined, work closely with the
DOH CO and CHD in determining the final eligible population based on the inclusion and
exclusion criteria as provided in the DOH guidelines.
c. Ensure that data in the CEIR are complete. And triangulate the accuracy of the profiling
data with existing data available in the LGU.
d. Determine the eligible population per municipality/city.
e. Then, disaggregate the eligible population by barangay and/or implementing unit.

Here is a sample form in determining the eligible population in the area:

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Figure 11. Sample form in determining the eligible population.

Table 13. Disaggregated eligible population by barangay / health facility.

Barangay Barangay Barangay/ Barangay/
Eligible Population TOTAL
/HF 1 /HF 2 HF 3 HF 4
1: Frontline Health Workers
a) Public and private health facilities
(Hospitals, TRCs and TTMFs)
b) Public health workers (all RHU/CHO
personnel; PHO, PDOHO, CHD and CO
field workers) and LGU contact tracers
c) Barangay Health Workers including
BHERTS
d) Other NGAs (DSWD, DepEd, DILG,
BJMP & Bureau of Correction)

2: Indigent Senior Citizens

3: Remaining Senior Citizens
4: Remaining Indigent Population
5: Uniformed personnel (PNP,
AFP, PCG, BFP, CAFGU)
TOTAL 100%

Criteria Step 2: Identify the implementing units in your area, and the number of
vaccination sites/posts, and plot in your operational spot map.

a. For COVID-19 vaccination, the fixed-post vaccination strategy shall be used (discussed
extensively in the succeeding section of this chapter). Implementing Units are defined as
establishments authorized to conduct the vaccination activity. On the other hand,
vaccination sites/posts are areas within the implementing units where the vaccination
administration proper is conducted. The following shall be utilized as implementing units:
i. Medical centers, hospitals and infirmaries (private and public)
ii. Rural Health Units
iii. Health facilities of other government agencies (e.g. AFP hospitals and facilities,

70
 BJMP/BuCor health facilities, and DepEd clinics)
iv. Private clinics
b. The implementing units may have several vaccination sites/posts within its vicinity, e.g. a
medical center can have several vaccination sites/posts within its vicinity.
c. Identify the implementing units as categorized on the table below and quantify the
vaccination sites/posts per implementing unit. If possible, determine how many vaccination
teams and AEFI/AESI composite teams can be accommodated in a vaccination post/site.
d. Plot in an operational spot map.

Table 14. List of Implementing Units and Vaccination Sites/Posts.

Implementing Units # of Vaccination Sites/Posts
a.
● Hospitals (government)
b.
a.
● Hospitals (private )
b.
a.
● Rural Health Units
b.
a.
● Health Facilities of other agencies
b.
a.
● Private Clinics
b.
TOTAL

Here are several points in making an operational spot map:

a. LGUs may utilize this link to map out facilities (except for private clinics) in their area:
https://nhfr.doh.gov.ph/rfacilities2list.php. The LGUs need to closely work with the private
sector in mapping out private clinics.
b. In addition to mapping of implementing units and vaccination sites/posts, the map may
include the following:
i. Roads/tracks (to determine distance of communities of eligible population to
implementing units).
ii. geographical landmarks and features (to determine geographical barriers)
iii. Areas with migrant workers, urban poor, ethnic minorities, new rural settlements and
groups in movement or unrest.

71
Critical Step 3. Identify the number of supervisors, vaccination teams, AEFI/AESI
composite teams and other personnel needed and available for the vaccination activity.

The guidelines on the composition of the vaccination workforce are detailed in the succeeding
section of this chapter.
a. Utilizing the information on the number of eligible population to be vaccinated in a round,
compute the required vaccination workforce, taking into consideration the duration of the
vaccination activity round. e.g. 50,000 (eligible population) ÷ 100 (numbers of vaccinees to
be vaccinated in a day) ÷ 14 (duration of the vaccination campaign) = 36 teams.
b. After determining the teams, determine the number of personnel required per team.
c. Coordinate closely with the health facilities and engage the health professionals and enjoin
them to participate in the vaccination activity (see Table X below).

Table 15. List of vaccination workforce, teams and personnel.

COMPOSITION # of Teams /
Individuals Required
Vaccination Team
2 For Screening and Assessment:

1 As Health Educator:
1 As Vaccinator:
2 As Documenter/Recorder:
AEFI/AESI Team
1 As Monitor/Responder:
1 As Surveillance Personnel:
Supervisor:

Critical Step 4: Assign vaccinees and teams to an implementing unit / vaccination post/site.

a. Determine the eligible population to be vaccinated in the implementing unit / vaccination

post/site.
i. Assign frontline health workers and uniformed personnel to health facilities where
they are employed/deployed.
ii. For frontline workers or uniformed personnel employed/deployed in an agency
without any health facility, assign them to RHUs and CHOs.
iii. For senior citizens and indigent population, assign them to the health facility nearest
to their residence.
b. Allocate vaccination workforce based on the number of eligible population assigned to the
implementing unit / vaccination site/post.
i. In close coordination with health facilities, the LGU may reallocate vaccination

72
 workforce of health facilities to vaccination posts with a high number of eligible
population assigned.

Table 16. Recommended vaccinees under the Eligible Priority Group A that particular implementing units can cater.
Operational Guidelines
● The following may be catered by Medical Center / Hospital / Infirmary (both private and public):
○ Frontline Health Workers, as defined in the DOH guidelines, in medical
centers/hospitals/infirmaries, Treatment Rehabilitation Centers (TRCs), Temporary Treatment
and Monitoring Facilities (TTMFs)
○ Senior Citizens
○ Indigent Population
○ Vaccination Team
● The following may be catered by Rural Health Units:
○ Frontline Health Workers employed/deployed/assigned in the public health sector, as defined in the
DOH guidelines; Barangay Health Workers and Barangay Health Emergency Response Teams,
employees manning close-setting facilities and long-term care facilities, e.g. orphanage, home for the
aged, women’s crisis centers, among others; and social workers providing social amelioration and
social services in the communities; and LGU-hired/deployed/designated or DILG-hired contact
tracers; Senior Citizens
○ Indigent Population
○ Uniformed personnel from the Philippine National Police, Bureau of Fire Protection, Philippine
Coast Guard
○ Vaccination Team
● The following may be catered by Private Clinics:
○ Frontline Health Workers, as defined in the DOH guidelines, working in private clinics
○ Senior Citizens
○ Indigent Population
○ Vaccination Team
● The following may be catered by Health Facilities of Government Agencies:
○ Frontline Health Workers employed/deployed/designated/assigned in health facilities managed by
the Department of Education, Armed Forces of the Philippines, Bureau of Jail Management and
Penology, Bureau of Corrections; frontline workers, as defined in the DOH guidelines,
employed/deployed/designated/assigned in BJMP and BuCor
○ Uniformed personnel from the AFP, CAFGU
○ Vaccination Team

Table 17. Sample for the assignment of vaccinees and vaccination workforce to vaccination posts/sites.
Bara- Vaccination Post Eligible No. of No. of Gap No. of No. of Gap No. of No. of Gap
ngay Population Vaccination Available Composite Available Supervisors available
assigned to Teams required Vaccination Teams Composite required supervisors
vaccination Teams required Teams
posts

B1 RHU 1 5,467 8 4 4 8 6 2 3 2 1

Private 600 1 1 0 1 1 0 1 1 0
Clinic 1

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 B2 Hospital 1

DepEd
Clinic 1

Critical Step 5: Estimate the vaccine requirement and ancillary supplies needed

a. Develop a budgeted cold and logistics plan

b. Determine the logistics required for the implementing units and vaccination posts. The
following are the minimum required.

Table 18. Vaccines and logistics required.

Logistics Formula

Vaccines ● Still to be determined: Eligible population ÷ __ ( ___doses per via) x ___

(wastage factor) = Total # of COVID-19 vaccine vials
Diluents ● Still to be determined
AD syringes ● Still to be determined
Mixing syringes ● Still to be determined
AEFI /AESI kits ● At least one AEFI/AESI kit per composite team
Safety Collection Boxes ● Total ADS + Total Mixing syringes)/100 x1.1 (WF) = Safety Box Quantity
(SCBs) Requirement

PPEs ● Face mask: Total HR x 2 masks/day x 7 days x 2 rounds; Face Shield: Total
HR x 1 face shield

Alcohols, cottons ● Alcohol: 1 bottle of alcohol/HR per day x 7 days x 2 rounds; 2 cotton balls
per vaccinee x 2 rounds
Vaccine carriers and ice
packs ● 1 vaccine carrier per 1 Vaccination Team

Vaccine refrigerators ● Still to be determined

Thermal Gun, BP
Apparatus, Stethoscope, ● 2 set per 1 Vaccination Team
Pulse Oximeter
Immunization cards ● 1 immunization card per vaccinee
Campaign Forms and
Checklists ● 1 set per team/day

Cot beds ● 1 bed per composite team

Ambulance ● 1 ambulance per implementing unit

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Critical Step 6: Identify gaps in cold chain capacity

Determine the cold chain capacity and identify gaps. Coordinate closely with the CHDs on the
logistics to be provided by the national and regional health offices.

a. Refrigerators: make an inventory of refrigerators and freezers specifying model,

manufacturer, number, energy source and the net vaccine and coolant-pact storage capacity.
b. Electrical System: check electrical system for reliability, accessibility, quality and security.
c. Vaccine Carriers: Evaluate number of cold boxes, vaccine carriers and coolant-packs.
Conduct an inventory of existing equipment at each implementing unit.
d. Temperature Monitoring: Assess the number and condition of
thermometer/temperature monitoring devices, temperature monitoring sheets.

Critical Step 7: Ensure timely delivery of vaccines and ancillary logistics

a. Develop a delivery and distribution plan for vaccines and ancillary logistics.
b. Coordinate with CHD on the delivery of vaccines and ancillary logistics that the National
Government will provide.
c. Consider in the delivery and distribution plan the timeline for the LGUs to deliver vaccines
and ancillary logistics to implementing units.
d. Coordinate with the CHD or CO on the direct delivery of certain vaccines to implementing
units.

Table 19. Sample Delivery Plan.

Quantity Date of Delivery

Vaccines

Diluents

AD syringes

Mixing syringes

AEFI Kits

Safety Collection Boxes

Face Masks

Face Shield

Alcohol

Cotton

Campaign Forms and Checklists

75
 Others

Table 20. Sample Distribution Plan.

Vaccination Post/Site # Vaccines # AD # Mixing # # AEFI # Safety # Face # Face # # Cottons Others
Syringes Syringes Diluents Kits Collection Masks Shields Alcohols
Boxes

Hospital 1

Hospital 2

RHU 1

RHU 2

Critical Step 8: Prepare a Daily Vaccination Session Plan (daily itinerary)

a. Plot the activities or assignment of each implementing unit / vaccination post on a daily
basis. Include in the plan:
i. Number of teams required daily
ii. Expected number of vaccinees to be vaccinated per day
iii. Transportation mechanism for the vaccinees and the teams, ensuring physical
distancing is considered in computing the transportation sitting capacity required
iv. Resources needed for the vaccination post, and its quantity.

Table 21. Sample daily vaccination session plan.

Date of Vaccination Assigned Eligible Daily Target to Transport Transport Resources needed with
Immunization Posts Vaccination Teams population be Vaccinated mechanism for mechanism for quantity
Schedule and Composite teams vaccinees
Teams

March 15 Hospital 1 Team 1 upto Team Frontline 300 3 hired vans none vaccines (#)
3 Health syringes (#)
Workers Safety collector boxes
(4)
Vaccine Carriers (3)
Ice Packs (12)
and etc
March 18 Hospital 2 Team 6-10 Senior 500 8 vans 10 jeepneys vaccines (#)
Citizen in syringes (#)
the AM Safety collector boxes
Indigent (6)
Population Vaccine Carriers (5)
in the PM Ice Packs (20)
and etc

Critical Step 9: Develop a communication plan for community advocacy, social

mobilization, partnership and engagement

a. Determine the following elements of the Demand Generation and Risk Communication

76
 microplan (see sample plan below):
i. Activities
ii. Indicators
iii. Target
iv. Baseline
v. Timeframe
vi. Responsible person/unit
vii. Budgetary requirements
viii. Funding source

Table 22. Sample demand generation and communication plan.

Activities Indicators Target Baseline Time Responsible Budgetary Funding
frame person/unit requirements Source

BEFORE THE MASS IMMUNIZATION CAMPAIGN

1. Briefing and feedback 100% of target key local

with LCEs, city officials are briefed on
administrator, LGU the COVID-19
HEPOs, public vaccination campaign
information officer,
DRRMO, and other key
local officials

2. Dialogues and/or
capacity building with
local partners and local
leaders

a. Barangay chairmen, 100% of target barangay

BHWs, BHERTs, and
other barangay officials
chairmen, BHWs,
BHERTs and other local
officials are oriented
and/or capacitated on the
COVID-19 vaccination
campaign

b. Community-based 80% of target

leaders and
representatives of
community-based
organizations (homeowners
associations, senior citizens,
women's groups, transport
groups, youth groups, indigenous
peoples)
community-based leaders
and representatives from
community-based
organizations oriented
and/or capacitated on the
COVID-19 vaccination
campaign

c. Representatives of 80% of target

Faith-based groups
representatives of faith-
based groups oriented
and/or capacitated on the
COVID-19 vaccination
campaign

d. NGOs, CSOs, civic, 80% of representatives

and other organizations NGOs, CSOs, and other
operating in the city organizations given
oriented and/or

77
 capacitated on the
COVID-19 vaccination
campaign

e. local medical societies 80% of target

and networks representatives of local
medical societies and
networks oriented and/or
capacitated on the
COVID-19 vaccination
campaign

f. private elementary and 80% of target

high school teachers representatives of private
elementary and
highschool teachers
oriented and/or
capacitated on the
COVID-19 vaccination
campaign

3. Development,
production, and/or
dissemination/posting of
communication materials

a. Development and/or # of communication

printing of materials developed
communication materials

b. Distribution and # of streamers or posters

posting/installation of installed
streamers, posters, and
other communication # of flyers distributed
materials (consider public
markets, transport terminals,
ports, health facilities, day care
centers, commercial areas)

4. Awareness-raising
activities

a. Announcements via # of announcements

local public address made
system(s) - e.g. mobile
public address system,
community megaphones

b. Awareness-raising # of activities conducted

activities for eligible
population (group
orientation;
announcements;
barangay assemblies;
townhall meetings; online
Q&A sessions)

c. Awareness raising and # of activities conducted

engagement via the mass
media and social media
platforms (e.g. Facebook,
Twitter, Instagram,
Youtube)

78
d. Awareness-raising # of awareness-raising
activities for hard-to- activities for 'special'
reach or special populations conducted
populations (e.g. areas
with security issues,
relocated populations,
mobile and transient
families, homeless)
- Identifying hard-to-reach
or special populations
- Conduct of local strategies
to reach hard-to-reach or
'special' populations

e. City-level launching or # of city-level kick-off

kick-off activity activities conducted
- Form committee; assign
tasks; coordinate with
national task group for
simultaneous launch
- Prepare programme or
activity plan, with budget;
speeches or talking points
- Send invitations;
coordinate logistics support
- Conduct kick-off activity

5. Pre-campaign # of pre-campaign
monitoring (check for monitoring activities
visibility of communication conducted
materials e.g. streamers;
awareness of parents/caregivers
about the campaign; activities
conducted by local officials and
partners in support of the
campaign)

a. Documentation of pre- Type of documentation

campaign activities (e.g. used (video, audio, photo,
video, photo) narrative)

b. Coordination meetings # of coordination

on advocacy and social meetings conducted
mobilization

DURING THE MASS IMMUNIZATION CAMPAIGN

1. Monitor the progress of # of monitoring activities

immunization activities; conducted
check for possible issues
including refusals,
rumours, misinformation;
apply corrective actions,
if needed

2. Continuing social
mobilization activities
(add details below; some
awareness-raising activities
during pre-campaign period may
be continued until end of the
campaign period and/or when
all children have been
immunized)

AFTER THE MASS IMMUNIZATION CAMPAIGN

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1. Post-campaign # of post-campaign
assessment meetings and assessment meetings and
other activities other related activities
conducted

2. Meetings with local # of meetings conducted

partners to report on
campaign accomplishment
and to thank them for their
support; agreements to
maintain/sustain the
partnership

3. Preparation and # of reports submitted

submission of campaign
documentation report(s)

Critical Step 9: Prepare a supervision and monitoring plan and schedule.

a. Ensure that supervisors and monitors are identified. Coordinate with implementing units to
identify their vaccination team supervisors and/or implementing unit supervisors (see
section on vaccination workforce).
b. Assign them to areas, especially areas needing technical assistance and support. If human
resource is scarce, prioritization of areas shall be determined for the deployment of
supervisors.
c. Map the areas needing supervisory work.

Table 23. Sample form for supervision and monitoring plan.

Region/Province: _____________________________ LGU: _______________________________________

Implementing Unit: ___________________________ Date: _______________________________________

Name of Team Number Name of Vaccination Mode of Start Date End Date Contact Number
Supervisor / and Name of Posts and Transportation
Monitor VT Leader Implementing Units VT Leader Supervisor

Rosana delos Team 1 - Carlos PGH Van March 19 June 19 0917 789 0915 422
Santos Reyes 3 vaccination posts 6534 5623

Judith Dulay Team 2 - AJ Pasig RHU 1 Van March 19 June 19 0998 567 0923 673
Cruz 1 vaccination posts 2317 6423

Critical Step 10: Prepare an AEFI/AESI management, surveillance and response plan

a. Determine how many AEFI/AESI kits are required per vaccination post.
b. Ensure that each composite team has the following emergency equipment:
○ BP apparatus
○ Stethoscope
○ Penlight
○ Cot Bed / Stretcher

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 c. Identify AEFI/AESI referral facility for each composite team, and identify contact person
in the referral facility and his/her contact numbers.
d. Ensure that an emergency transport vehicle is on standby in the vaccination post.

Table 24. Sample from for AEFI preparation.

Vaccination No. of No. of Emergency Referral Contact Contact Assigned

Posts Composite AEFI/ AESI Equipment Facility Person Details Emergency
Team Kits Needed Transport
Assigned Vehicle

RHU 1 3 Teams 3 Kits (with Cot Bed / Pasig City Dr. Juan Dela 0917 569 RHU
(Team 1-3) complete Stretcher: 6 General Cruz 3455 Ambulance
items) BP: 3 Hospital Plate No. TG
Stet: 3 3485
Pen light: 3

Hospital 2

Critical Step 11: Develop a waste management plan

Details on what to prepare and what to plan are extensively discussed in the last section of this plan.
The required management of wastes may vary depending on the type of vaccines. The waste
management plan should be extensively laid out based on the recommendation of manufacturers.
For a minimum, the following steps must be undertaken:
a. Designate safe temporary storage for immunization wastes generated daily
b. Schedule and designate key responsible persons for waste management, waste transport and
waste storage and destruction (if necessary).
c. Identify healthcare waste treatment and final disposal facility

Table 25. Sample form for immunization waste management plan.

Vaccination Post/ Disposal Facility Contact Person and Schedule

Implementing Unit Contact Number

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 3. Mapping of Vaccination Workforce, Implementing Units and Vaccination
Sites/Posts

During the pre-implementation phase, it is essential that decision-makers such as the Local Chief
Executives (LCEs), planning officers and health officers, among others, are familiar and adept with
the guidelines in determining the vaccination workforce, implementing units and vaccination
sites/posts.

The Vaccination Workforce

For the COVID-19 vaccination campaign, a diverse set of professionals and personnel, both from
the public and private sector, shall be utilized as part of the vaccination workforce.

As more doses of vaccines become available during 2021- 2022, there will be a need to expand the
pool of skilled workforce to administer vaccines and to deliver the program. In particular, standalone
general practice private clinics and pharmacists can and have successfully delivered very significant
numbers of flu vaccines and can offer enhanced capacity for this program subject to agreement. This
vaccination program will also require significant increases in the number of administrative and
support staff, in this regard there may be opportunities to leverage the broader public service to
achieve this.

Thus, to ensure that sufficient workforce is available, the National Government shall engage and
include other professionals such as teachers, counsellors, pharmacists, medical and allied health
professionals and interns; and the private sector, as part of the vaccination workforce.

These are the minimum set of vaccination workforce needed:

Table 26. Recommended composition of the vaccination and AEFI composite teams, and other personnel needed in
the implementing units.

Team/Other Personnel Composition

needed

Vaccination Team (6) (2) for screening and assessment: Physician/Nurse/Midwife(1) as health educator:
Allied Professionals/ Volunteers from partner agencies (e.g. teachers, social
workers, medical students, etc)
(1) as vaccinator: Physician/Nurse/Midwife of RHU/Pharmacist (certified by
PRC)
(2) as documentor/recorder and vital signs-taker: Midwife/BHW/Health Staff /
Volunteers from partner agencies (e.g. teachers, social workers, medical students,
etc)

AEFI Composite Team (2) (1) to monitor and provide response: Paramedic/Nurse/Midwife
(1) to conduct surveillance: Surveillance Officer/ Nurse/Midwife/Pharmacist

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 Supervisors/Monitors (1) Vaccination Team Supervisor: preferably a physician, for at least three (3)
vaccination teams
(1) Implementing Unit Level Supervisor: for the entire implementing unit
(1) LGU Level Supervisor: for the entire LGU
Internal Monitors and Independent Monitors

Other personnel needed in Cold Chain and Logistics Officer/s

the implementing units Local Officials (barangay captains)
Security Personnel (PNP)
Drivers
Safety Officers (Barangay Tanods, among others)

Other personnel needed in Social mobilizers: BHWs and hospital staff (HR)
community/health facilities Navigators/Transport: BHWs and Local Officials, Health Facility Management

The following are the roles and responsibilities of each team and personnel:

Table 27. Roles and responsibilities of the vaccination workforce.

Teams and Personnel Roles and Responsibilities

1. Vaccination Team ● Man the vaccination administration area in the vaccination post/site
● Ensure that the vaccination administration procedure has been conducted
efficiently and correctly
● Ensure that reports and information are encoded truthfully and submitted timely

a. Personnel assigned ● Man the registration area

as documenter and ● Ensure that documents and identification presented by the vaccinee are valid
recorder ● Ensure that all information and data are encoded in the data management system
● Assist other team members, especially on vital signs taking
● Submit daily coverage, refusals and deferrals to the C/MHO

b. Personnel assigned ● Man the health education area

as health educator ● Ensure that equipment and IEC materials are available during the vaccination
post/area
● Provide information to vaccinees, particularly on the benefits of vaccination, the
possible adverse reactions, and how to seek help if with adverse reaction, either by
answering their queries, or providing them with IEC materials
● Facilitate the signing of the informed consent
● Coordinate with social mobilizers and navigators for those who were deferred and
those who refuse on-site.

c. Personnel assigned ● Man the screening and assessment area

for screening and ● Conduct physical examination and take the history of present illness (if
assessment applicable) and record in the CEIR
● Provide clearance for the vaccinee to be vaccinated. Those deferred for
vaccination shall be coordinated with the social mobilization team for follow-up

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 and shall be provided with a possible vaccination schedule

d. Personnel assigned ● Man the vaccine administration area

as a vaccinator ● Follow the step-by-step procedure of vaccine administration as recommended by
the manufacturer and as guided by the immunization protocols
● Completely fill-up the immunization card and encode the needed information to
the data management system
● Dispose syringe and vials accordingly

2. AEFI/AESI ● Man the post-vaccination area in the vaccination post/site

Composite Team ● Ensure that the vaccinee is monitored and observed for any adverse reaction in the
1st hour after vaccination
● Provide immediate intervention and response for vaccinees experiencing adverse
reactions on-site and refer them accordingly and timely

a. Personnel assign to ● Monitor and observe the vaccine for any adverse reaction in the 1st hour after
monitor and provide vaccination
response ● If the vaccinee has any adverse reactions, provide immediate
intervention/treatment
● Refer vaccinee/s with adverse reaction/s to appropriate AEFI/AESI referral health
facilities in a timely manner
● Provide the vaccinee with information on what signs and symptoms he/she
should watch for at home and where he/she should proceed to for treatment

b. Personnel assign for ● Monitor and observe the vaccine for any adverse reaction in the 1st hour after
surveillance vaccination
● If the vaccinee has any adverse reactions, conduct surveillance investigation
● Follow-up the vaccinee/s for any adverse reaction/s at home

Supervisors and Supervisors

Monitors ● Supervise and oversee the vaccination activity
● Address concerns and coordinate accordingly
● Ensure timely submission of reports
Monitors
● Monitor and evaluate the quality of vaccination implementation
● Provide feedback to VOCs

a. Vaccination Team ● Visit Vaccination Teams at least once a day for supportive supervision using the
Supervisor Supervision Checklist
● Compile vaccination team reports, analyze them and report to higher level
● Review team performance and undertake corrective actions if needed

b. Implementing Unit ● Visit Vaccination Teams with Team Supervisors, at least once a day for supportive
Level Supervisor supervision using the Supervision Checklist
● Compile and review vaccination team reports, analyze them and report to higher
level
● Review team performance and undertake corrective actions if needed

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 ● Communicate daily with Coordination team in the VOC

c. LGU Level ● Visit implementing units 1-2 weeks prior to the campaign to monitor progress in
Supervisor preparedness.
● Support training and microplanning activities
● Review submitted reports, compile and analyze health center level data

d. Monitors and ● Visit vaccination sites and complete monitoring forms

Independent ● Monitor the vaccination implementation and ensure that it is based on the
Monitors guidelines set by DOH
● Participate in meetings of the coordination team
● Assist in troubleshooting, as needed

The following are the pertinent operational guidelines on the vaccination workforce:
a. The Local VOCs and City/Municipal Health Officers shall be responsible in mapping and
identifying the vaccination workforce and in assigning them to vaccination sites/posts, in
coordination with the implementing units.
b. One vaccination team shall be complemented with at least one AEFI/AESI composite team.
c. In minimum, three (3) or more vaccination teams and three (3) or more AEFI/AESI
composite teams shall be assigned in a vaccination post/site.
d. Each vaccination team shall have a target of 100 vaccinees per day.
e. A supervisor shall oversee at least 3 vaccination teams and 3 AEFI/AESI composite teams.
f. At least one (1) Safety Officer is designated for every vaccination post. He/She shall ensure
that minimum health standards are implemented and observed at all times.
g. The LGUs shall develop a contingency plan to ensure availability of sufficient number of
vaccination workforce available considering the following:
i. Human resource assigned for the COVID-19 pandemic response shall NOT be
utilized as part of the vaccination workforce.
ii. Possibility of COVID-19 infection among the vaccination workforce.
iii. Services offered in health facilities shall not be hampered because of the vaccination
campaign. If so, disruption must be kept to a minimum.
iv. Possibility of vaccinated health workers experiencing adverse reaction, either mild or
severe, after vaccination.

The Implementing Units and Vaccination Sites/Posts

A permanent fixed-post vaccination strategy shall be used in the conduct of the COVDI-19
vaccination campaign. As defined in the National Immunization Program, permanent fixed-posts
are posts located at health facilities where there is sufficient capacity and equipment to immediately
respond and refer AEFI/AESI cases, and where sufficient health human resources are available.

Therefore, the following shall be utilized as implementing units:

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 a. Medical centers, hospitals and infirmaries (private and public)
b. Rural Health Units
c. Health facilities of other government agencies (e.g. AFP hospitals and facilities,
BJMP/BuCor health facilities, and DepEd clinics)
d. Private clinics

The LGUs shall ensure that all implementing units, including private health facilities, adhere to the
protocols required for an implementing unit / vaccination posts/sites. No implementing unit shall
be allowed to conduct vaccination activity without compliance to the protocols required of a
vaccination post.

4. Human Resource Management and Training

Introduction of a new vaccine requires training activities on components of the National

Deployment and Vaccination Plan and compliance with vaccine administration standards. These
activities should be geared to personnel at all levels participating in the vaccination program.

The national training plan shall target:

● National and departmental coordinators of areas directly or indirectly related to vaccine
introduction (e.g., information system, communication, cold chain, surveillance, etc), who
will facilitate the vaccination processes at the district/municipality and local levels.
● Vaccination workforce who will directly or indirectly conduct the vaccination

Training in specific components of the plan should include participation by representatives of the
scientific community, social security, and other relevant departments to standardize knowledge
regarding the use of the new vaccine.

The COVID-19 Vaccine Deployment and Vaccination Program will be delivered by skilled and
trained staff working in a variety of delivery locations. All staff working in the program will receive
training relevant to their role in the team and service.

Training programs will be delivered through blended learning: on-line, and when required, in
person. In addition to the specialist clinical training required for vaccinator staff, induction and
orientation training will be provided for all staff working in implementing units.

Training Curriculum

In keeping with the guidance provided for the introduction of new vaccines, a training package is
developed by DOH, together with WHO and Unicef. The training package will include a
presentation slide deck and instructional job aids. The training will cover a total of nine (9) main
topics including 1) Microplanning, 2) Masterlisting and Data Management, 3) Logistics and Cold
Chain Management, 4) Risk Communication and Social Mobilization, 5) Addressing the

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Psychological Barriers to COVID-19 Vaccination, 6) Vaccine Administration, 7) Vaccine Safety,
Surveillance and Response, and 8) Waste Management and Reverse Logistics and a module on 9)
Training Skills and managing virtual training that shall capacitate trainers on the use of technology
and virtual platforms not only for training activities but also online/ virtual activities. During the
training, a review of the Standard Operating Procedures will be conducted.

Training Execution

Vaccination experts from the WHO, United Nations Children’s Fund (UNICEF) and the DOH
will provide the initial training and post-training support for the Core of Trainers. The DOH
trainers will in turn conduct cluster-based Training of Trainers (TOT) for the 5 identified clusters:
North Luzon, South Luzon, Visayas, North Mindanao and South Mindanao who in turn will
organize regional training teams. The regional training teams will be responsible for training
vaccinators from the local implementing units. These teams will also be responsible for post-training
supervision of the vaccinators. Relevant implementing partners will also be leveraged to provide
training support where necessary. The table details the roles and responsibilities of the training teams
at the different levels of the government.

Table 28: Roles and responsibilities of the training teams.

Level of Training Team Roles and Responsibilities

WHO, UNICEF and DOH ● Develop/ Co-Develop the training materials

vaccination experts and trainers ● Conduct the initial ToT for the Core Trainers
● Provide post training support to the Core trainers

DOH Cluster trainers ● Identify regional training teams

Conduct TOT for the regional training teams
● Work with the regional training teams to develop regional training plans
● Provide oversight for the cascading of the trainings within each region
● Monitor the standards of and the implementation of training for the
local implementing units.
● Conduct monitoring and evaluation of the training activities

Regional training teams ● Conduct training needs assessment

● Develop regional training plan
● Conduct trainings for the local implementing units
● Conduct post training supportive supervision, observation and
mentoring for the local implementing units
● Implement quality improvement as needed based on gaps identified
during the post training support activities

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The following dates of training are:

Table 29. Training schedule.

Dates of Training Training Training Participants

December 29-30, 2020 Core of Trainer’s Training Designated DOH Core Trainers from DOH central office

Designated trainers from:

● DOH Centers for Health Development Metro
Manila
● Medical staff from other national government
implementing agencies (DILG (BFP, PNP, BJMP),
DSWD, DepEd, DND (AFP), DOJ (BuCor),
DOTr (PCG))

January 12-13, 2021 NCR and Luzon Training Designated trainers from:
● DOH Centers for Health Development
● Selected government and private hospitals
January 14-15, 2021 Visayas and Mindanao ● Provincial Health Officers
Training ● Medical staff from other national government
implementing agencies (DILG (BFP, PNP, BJMP),
January 20-21, 2021 BARMM Training
DSWD, DepEd, DND (AFP), DOJ (BuCor),
DOTr (PCG))

January 22-31, 2021 Training of Implementing ● Provincial and local health units
Units ● Remaining hospitals and other health facilities

Post-training supportive supervision

After training of the trainers, the DOH Core Trainers shall continue to support the trainers through
post-training supporting supervision or coaching/mentoring sessions. Since this is a new vaccine and
vaccination program, a more hands-on approach shall be implied. A training kit was created which
contains the different training materials and updates about the program. The DOH core trainers
assigned to 5 Clusters (N. Luzon, S. Luzon, Visayas, N. Mindanao and S. Mindanao) shall assist the
trainers in their training activities and will look into the following areas:

1. Use of updated and standard training reference materials.

2. Planning and conduct of training.
3. Capacitating the target number of vaccinators and composite teams.
4. Readily addressing issues and concerns of the trainees
5. Continuous coordination with different implementing agencies and institutions.
6. Ensuring that the different implementing agencies are capacitated on the COVID-19
Immunization Program Implementation.

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They shall virtually monitor and address issues and concerns encountered. Field monitoring may be
conducted as necessary. The post training supervision and monitoring shall be conducted alongside
with the DOH regional trainers and partner implementing agency focal persons.

5. COVID-19 Vaccine and Cold Chain Capacity Inventory and Logistics

Management

The purpose of the vaccine “cold chain” is to maintain product quality from the time of
manufacture until the point of administration by ensuring that vaccines are stored and transported
within the recommended temperature ranges. Vaccine potency, meaning its ability to adequately
protect the vaccinated patient, can diminish when the vaccine is exposed to inappropriate
temperatures. Once lost, vaccine potency cannot be regained. It is essential that all those who handle
vaccines and diluents know the temperature sensitivities and the recommended storage temperatures
for all the vaccines.

In the pre-implementation phase, in order to maintain a reliable vaccine cold chain and logistics
management at the LGU level, the following key procedures shall be observed:
a. Receive vaccines logistics requirement for the vaccination campaign.
b. Count ALL vaccines and logistics (syringes, SCBs, re-sealable plastic, among others) received
to ensure NO short shipment.
c. Check the vaccine label and ensure that it is intact.
d. Store vaccines and diluents within the required temperature ranges at all sites/levels. Keep
vaccines in appropriate vaccine refrigeration equipment. Keep all COVID-19 vaccine vials
together in the same cold chain equipment at all times.
e. Label storage equipment containing COVID-19 vaccines properly.
f. Use a temperature monitoring device to ensure temperatures remain according to the
recommended temperature.
g. Pack and transport vaccines to and from implementing units according to recommended
procedure. Transport vaccines to immunization sessions in a vaccine carrier, correctly
packed using coolant packs that have been properly prepared.
h. Keep vaccines and diluents within recommended cold chain conditions during vaccination
sessions. During the vaccination sessions, fit a foam pad (if available) at the top of the vaccine
carrier.

The LGU and in implementing units, one person shall be in-charge of logistics and cold chain
management. An alternate shall also be identified to take over if the in-charge is absent. Their
responsibilities shall include:
a. Checking and recording vaccine temperatures twice daily; in the morning and at the end of
the session or day.
b. Properly storing vaccines, diluents and ice packs.

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 c. Handling preventative maintenance of the cold chain equipment.

6. Preparation of Vaccination Sites/Posts

A few weeks or days prior to the conduct of the vaccination activity, the LGUs and implementing
units shall ensure that all vaccination posts/sites are prepared and fully equipped.

The vaccination post/site shall comply with the minimum health standards and shall have sufficient
equipment for disinfection and sanitation. The dimension of the vaccination site/post shall be taken
into consideration possible crowding in the post-vaccination area. It is recommended that
implementing units shall utilize rooms of the health facilities for the vaccination activity, such as
conference rooms, auditoriums, theaters, health facility gymnasiums, among others. If these types
of facilities are not available, the implementing units can put up tents or temporary buildings within
the vicinity of the implementing unit, such as in facility grounds, parking lots, and open spaces,
among others.

The vaccination post/site shall have the following areas (as shown in Figure x):
1. Waiting Area. The waiting area shall be prepared for vaccinees waiting for their vaccination
turn.
2. Vaccination Area: The vaccination area shall have at least three (3) vaccination teams and
three (3) AEFI/AESI composite teams. Each area shall have several sanitation areas for each
vaccination team. The following areas, arranged in sequential order, shall be set in placed:
a. Registration Area: An area where the vaccinee’s information and documents are
checked and submitted. Each vaccination team shall have their respective areas in the
registration area. Equipment needed to scan the QR code should be available in this
area.
b. Health Education Area. There shall be one health education area for the whole
vaccination site/post. In this area, IEC materials, such as pamphlets, leaflets and
brochures shall be made available. Also, a projector or a TV shall be set up in this
area, or the least, a flipchart, for health education purposes.
c. Screening Area. Since the screening procedure may take longer compared with other
areas, it is advised that at least two screening stations per team shall be set up.
Equipment needed to scan the QR code should be available in this area.
d. Vaccination Area. Each vaccinator shall have his/her own area. The vaccination area
should have an accessible cold chain equipment to store the vaccines in the
vaccination post/site.
3. Post-vaccination Monitoring Area. Since the observation of vaccinees post-vaccination will
take 30 minutes to one hour, it is expected that there might be pooling or crowding of
vaccinees in this area. Thus, this area must be spacious enough to accommodate all vaccinees
and to allow observance of physical distancing measures. In addition, equipment needed for
AEFI response must be available and accessible.

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Figure 12. Vaccination site/post lay-out.

The following equipment is needed in the vaccination site/post.

Figure 13. Equipment required in the vaccination site/post.

Implementation Phase

Mobilizing the eligible recipients

During the vaccination activity, eligible recipients who have successfully registered for vaccination
shall proceed to the assigned vaccination posts/sites based on the schedule provided or they may be
fetched from assigned pick-up points through previously arranged transport mechanisms. BHWs,
local officials and other personnel may also do house-to-house visits to mobilize eligible recipients
who have successfully registered for the vaccination, so that they can proceed to the assigned
vaccination site (see Figure 12).

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Figure 14. Illustration of the mobilization of eligible recipients for the actual COVID-19 vaccination.

Intra-campaign Vaccine Cold Chain and Logistics Management

Daily during the vaccination campaign round, the preparation of vaccines and logistics is a very
important activity to be undertaken by the LGU/health facility supervisor and cold chain manager.

The following steps shall be undertaken every vaccination day:

1. Before every vaccination activity, prepare the vaccine carriers and the ice packs.
2. In each vaccine carrier, arrange the frozen ice packs exactly as recommended on the
manufacturer’s instruction on the inside of the lid. Do not cover the frozen ice packs in
paper.
3. Prepare re-sealable plastic bags and an extra one for opened/used vials (after the vaccination
day).
4. Place 20 vaccine vials in one re-sealable plastic bag. The number of vaccines to be used per
vaccination team shall be determined prior to the activity.
5. Put the resealable plastic with the vaccines in the middle of the vaccine carrier to protect
them from damage due to condensation.
6. Daily issuances of vaccines should be recorded in the distribution and collection form
acknowledged by the vaccination team leader / supervisor.
7. At the end of each vaccination day, all vials (unopened, fully or partially used) shall be placed
in resealable plastic bags and returned to the same health facility where they received the
vaccines in the morning. The facility supervisor shall record the vials received at the end of
each vaccination day.
8. Health facilities / vaccination distribution points must then keep the unopened usable vials
in the cold chain. The vaccines can be used for the next day.

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 9. All opened or unusable vials contained in resealable plastic by twenties (20s) must be kept in
a sack and be picked up by the CHD at the end of the vaccination round for disposal.

Table 30. The vaccine distribution and collection form.

Vaccination Administration

Prior to the vaccination, the vaccinee will be provided with a vaccination date and time schedule,
and an immunization card with a QR code, which he/she will bring to the vaccination post, to
ensure smooth implementation of the vaccination activity and avoid congestion in the vaccination
site/post. No walk-in vaccination shall be accommodated since vaccines allocated for the day are
sufficiently allocated for the projected number of vaccinations to be conducted in a day. However,
a walk-in eligible recipient shall be scheduled and provided with an immunization card with a QR
code immediately, and advised accordingly.

Upon arrival at the vaccination site/post, the vaccinee shall wait for his/her turn in the waiting area.
Upon entry in the waiting area, the vaccinee’s temperature will be checked. The Safety Officer shall
ensure that physical distancing measures shall be implemented at all times at the waiting area.

Each vaccinee shall be assigned to a specific vaccination team. When his/her turn arrives, he/she will
proceed to the vaccination area, and in a stepwise approach, he/she will proceed from the registration
area, health education area, screening area and lastly, to the vaccination area.

At the registration area, the vaccinee shall present his/her immunization card with QR code and
shall be scanned. The profile of the vaccinee shall be retrieved in the computer system and the
vaccinee’s identity shall be verified by presenting his/her government ID (eg. driver’s license, PRC
license, PhilHealth ID, UMID, Passport, etc). Other relevant documents shall be presented at the
registration.

The vaccinee shall then be directed to the Health Education Area where health educators shall
present IEC materials and answer any question the vaccinee may have regarding the COVID-19

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vaccine. Once all questions are answered, the vaccinee shall be asked to sign the Final Consent form.

At the Screening Area, the personnel assigned shall scan the patient’s QR code and conduct history-
taking and physical examination to ensure the eligibility of the vaccinee. Using both the CEIR and
screening form hard copy, the health worker shall update the vaccinee’s profile and determine
whether or not he/she is qualified to receive the vaccination.

The vaccinee shall then be directed to the Vaccination Area where the vaccine shall be administered.
Once vaccinated, the QR code shall be scanned and the vaccination details (e.g. date of vaccination,
vaccine manufacturer, batch number, lot number, name of vaccinator and signature) shall be
recorded in the CEIR and immunization card.

After vaccination, the vaccinee shall be observed for adverse reactions for 30 minutes to one hour at
the post-vaccination monitoring area. The post-vaccination monitoring area must be closely linked
with an identified referral health facility. After an hour, once cleared, the vaccinee shall be provided
with instructions about the possible adverse reaction that the vaccinee might experience and the
location of facilities where he/she can proceed should he/she experience adverse reactions.

Figure 15. The vaccine administration flow.

A checklist detailing the steps to be followed by the vaccination and AEFI/AESI composite teams
shall be placed in each designated area. In the vaccination area, a specific checklist for each type of
vaccine shall be provided. As of January 18, 2021, information on vaccine administration of Pfizer
and Moderna vaccines are available. In the checklist, the following steps are detailed:

Registration Area:
1. Ask the vaccinee to sanitize hands and get his/her temperature.
2. Scan QR Code or Register ID number.
3. Verify the vaccinee's identity with any government-issued ID (contains photo, birthday,
signature) or passport.

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 4. Remind the vaccinee to follow the minimum health standards within the vicinity.
5. Direct the vaccinee to the Health Education and Final Consent Area.

Health Education and Final Consent Area:

1. Group the vaccinees (even those from other teams) to at least 6-12 individuals.
2. Play a DOH Explainer Video to the Group.
3. Encourage the vaccinee to ask questions and clarifications and address issues that he/she may
have.
4. Explain to and educate vaccinee on COVID-19 Vaccine - what it is, how it protects,
administration and possible side effects.
5. Explain to the vaccinee that he or she may opt to receive the 2nd dose from another facility
provided that the 2nd dose is the same brand as the 1st dose.
6. Instruct patient on post-vaccination care:
a. Put ice pack / ice on the injection site for 15 minutes 3x a day, in the first 24 hours
after vaccination. Report any AEFI to the clinic/hospital.
b. For any serious AEFI, proceed immediately to the nearest Emergency Room.
7. Provide educational materials (pamphlets with FAQs) at suitable reading levels to the
vaccinee and available in vaccinee’s local language.
8. Provide Vaccine Information Statements (VIS) or Emergency Use Authorization (EUA)
forms, if required.
9. Ask vaccinee to sign the Final Consent Form.
10. Direct the patient to the Screening Area.

Screening Area:
1. Scan QR Code
2. Conduct history-taking
❏ Focus on the present history (past history and co-morbidities are gathered during pre-
registration and profiling)
a. Is the vaccinee currently experiencing the ff symptoms or have experienced the ff in
the past 14 days?
❏ Fever
❏ Headache
❏ Cough
❏ Colds
❏ Sore throat
❏ Shortness of breath or Difficulty in breathing
❏ Chest pain
❏ Abdominal pain

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 ❏ Changes in bowel movement
❏ Loss of taste/smell
❏ Fatigue/weakness
❏ Others: ____________________________________
b. Is the vaccinee on any blood thinner or any medication that affects the immune
system?
c. Has the vaccinee received any vaccination in the past 4 weeks?
d. Has the vaccinee experienced any serious reaction after receiving a vaccine?
e. Has the vaccinee previously received a COVID-19 Vaccine?
If yes, specify: __________________________________
f. For women: Is the vaccinee pregnant/ breastfeeding or is there a chance she could
become pregnant during the next month?
3. Conduct Physical Examination
a. Take the Vital Signs
❏ Heart rate: _______ beats/min (N: 60-100 bpm)
❏ Respiratory rate: _______ breaths/min (N: 12-20 bpm)
❏ Blood pressure: _________ (N: < 120/80)
❏ Oxygen saturation: ________ % (N: 95-100%)
b. Perform Cardiovascular Examination
❏ Normal rate and rhythm
❏ (+) Murmurs
❏ (+) Irregular heart rate and rhythm
c. Perform Respiratory Examination
❏ Clear lung fields
❏ Adventitious breath sounds, specify: _________________

Vaccination Area (Pfizer Vaccine):

Prepare the Vaccine

1. Follow aseptic technique. Perform hand hygiene before vaccine preparation, between patients,
when changing gloves (if worn), and any time hands become soiled.*
2. Remove vaccine from the freezer or refrigerator. Allow vaccine to come to room temperature.
Vials can be held at room temperature for up to 2 hours before mixing. After 2 hours return
unmixed vials to the refrigerator.
3. Before mixing, check the expiration dates of the vaccine and diluent. NEVER use expired
vaccines or diluent.
4. With the vaccine at room temperature, gently invert the vial 10 times. Do not shake the
vial. If the vial is shaken, discard the vaccine. The vaccine is a white to off-white in color and
may contain opaque particles. Do not use it if liquid is discolored.

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 5. Using a new, sterile alcohol prep pad for each vial, wipe off the stoppers of the diluent and
vaccine vials.
6. Using a 21-gauge (or narrower) needle, withdraw 1.8 mL of 0.9% sodium chloride (normal
saline, preservative- free) into a mixing syringe. After use, discard diluent vial and remaining
diluent.
7. Do NOT use bacteriostatic normal saline or other diluents to mix the vaccine.
8. Inject 1.8 mL 0.9% sodium chloride (normal saline, preservative-free) diluent into the vaccine
vial.
9. Using the mixing syringe, remove 1.8 mL of air from the vaccine vial to equalize the pressure
in the vaccine vial.
10. Gently invert the vial containing vaccine and diluent 10 times. The vaccine will be off-
white in color. Do not use if discolored or contains particulate matter. Do not shake. If the vial
is shaken, discard the vaccine.
11. Note the date and time the vaccine was mixed on the vial.
12. Keep mixed vaccine at room temperature (2⁰C to 25⁰C [36⁰F to 77⁰F]) and administer within
6 hours. Discard any unused vaccine after 6 hours. Do not return to refrigerator or freezer
storage.
Administer the Vaccine
1. Scan the QR Code and verify the patient’s identity (e.g. name and birthday).
2. Perform hand hygiene and aseptic technique.
3. Ensure staff has the correct PPE before administering vaccines.
4. Choose the correct equipment, including the correct needle size. Use a new, sterile needle and
syringe for each injection.
5. Cleanse the stopper on the vial of mixed vaccine with a new, sterile alcohol prep pad.
Withdraw 0.3 mL of mixed vaccine into the syringe. Ensure the prepared syringe is not cold to
the touch.
6. Remove any air bubbles with the needle still in the vial to avoid loss of vaccine. Use the same
needle* to withdraw and administer the vaccine, unless contaminated or damaged.
7. Administer the vaccine immediately by intramuscular (IM) injection in the deltoid muscle.
8. Update the vaccinee profile system with: date of vaccination, COVID vaccine manufacturer,
batch number, lot number, name of vaccinator.
9. Fill up the patient’s immunization card with vaccinee’s date of vaccination, COVID vaccine
manufacturer, batch number, lot number, name of vaccinator.
10. Direct patient to Post-vaccination Monitoring Area.

Vaccination Area (Moderna Vaccine):

1. Scan the QR Code and verify the patient’s identity (e.g. name and birthday).
2. Perform hand hygiene and aseptic technique.

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 3. Visually inspect each dose of the Moderna COVID-19 Vaccine in the dosing syringe prior to
administration. The white to off-white suspension may contain white or translucent product
related particulates. During the visual inspection,
● Verify the final dosing volume of 0.5 mL.
● Confirm there are no other particulates and that no discoloration is observed.
● Do not administer if the vaccine is discolored or contains other particulate
matter.
4. Administer the Moderna COVID-19 Vaccine intramuscularly.
5. Update the vaccinee profile system with: date of vaccination, COVID vaccine manufacturer,
batch number, lot number, name of vaccinator.
6. Fill up the patient’s immunization card with vaccinee’s date of vaccination, COVID vaccine
manufacturer, batch number, lot number, name of vaccinator.
7. Direct patient to Monitoring Area.

Post-Vaccination Monitoring Area:

1. Monitor and record patient’s vital signs every 15 minutes for 30 minutes to one hour post-
vaccination.
2. Play DOH videos and provide information to the vaccinee during the observation period.
a. Instruct the vaccinee on possible adverse reactions and when, how, and where to report
if he/she manifest signs and symptoms.
b. Provide information on post-marketing surveillance.
3. Observe the patient and watch out for any symptoms of shortness of breath, syncope and
anaphylactic reaction, or any reaction as stipulated by the manufacturer.
4. Respond and give first aid to vaccinee for possible AEFI/AESI.
5. Refer vaccinee to hospital for further management needed.

Infection Prevention and Control (IPC), Injection Safety, Management of Health Care
Waste and Reverse Logistics

All throughout the implementation phase, infection prevention and control measures must be
practiced. Table 32 shows minimum standards for IPC that must be practiced during the
vaccination.

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Table 31. Minimum infection prevention and control measures during COVID-19 vaccine administration

Aspect of vaccine Minimum IPC measures

administration

Vaccination post ● Open or well-ventilated areas

● Frequently disinfected areas
● Spacious enough to implement physical distancing, crowd control measures
● Limit number of vaccinees within the vaccination area to <24 individuals at a
given time.

Vaccination Team and ● Wear face mask and face shield

Composite Team, and other ● Practice hand hygiene before and after procedure/vaccine
personnel in the vaccination ● Limit contact between vaccinator and vaccinee to less than 15 minutes
site ● Daily self-monitoring for COVID-19 symptoms
● Log-in upon entering and exiting a vaccination area on a daily basis

Vaccinees ● Wear face mask and face shield

● Frequently practice hand hygiene
● Abide to physical distancing guidelines

Injection Safety

In addition to the IPC measures, injection safety must also be ensured during the vaccination.
Injection safety is the safe handling of all injection equipment, routine monitoring of the availability
and use of safe injection equipment and correct disposal of contaminated injection equipment.

The following injection safety guidelines shall be implemented:

1. Follow proper infection control practices and maintain aseptic technique during the
preparation and administration of vaccines (e.g., perform hand hygiene).
2. Never administer vaccines from the same syringe to more than one patient, even if the needle
is changed.
3. Never enter a vial with a used syringe or needle.
4. Do not use vaccines packaged as single-dose or single-use for more than one patient.
5. After use, immediately put syringes and needles in a puncture-proof sharps container.
6. Close safety boxes when they are ¾ full and lock boxes in a secure area.
7. Know how syringes are stored and destroyed at your facility.

Disposal of Immunization Wastes

Wastes generated at the health care facilities after vaccination may pose harm and risks to the health
care workers and communities if not properly managed. Health Care Waste Management (HCWM)

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is a process that helps in ensuring the proper management of health care waste from the point of
generation until disposal.

Department of Environment and Natural Resources (DENR) AO 2013-22 categorized health care
waste under the following subclassifications of miscellaneous wastes (Class M):

● Pathological or Infectious Waste (Waste No. M501)

● Pharmaceuticals and Drugs (Waste No. M503)

Understanding the health care waste management system, in general, requires proper planning and
implementation of managing wastes generated in the nationwide COVID-19 vaccination,
considering the complexity of the nature of the vaccines. Proper handling, storage, collection and
disposal of the wastes shall be followed to ensure protection of the environment and the general
public.

The health care facility or implementing unit shall identify personnel as part of the COVID-19
Vaccine Waste Team. The existing HCWM Committee of the health facility may also serve as the
Team. The Team shall develop a COVID-19 Waste Vaccination Plan and implement the said plan.
The plan shall include activities, resources needed, including budget, responsible person/s or unit/s,
and timelines. The Team shall be responsible that the vaccinators follow the guidelines on the proper
segregation or sorting, handling and disposal of the waste. The Team shall ensure that all collected
wastes in the temporary storage areas of the HCF are properly collected and disposed either on-site
or offsite.

The COVID-19 vaccination may generate the following types of waste:

1. Hazardous wastes: these include the contaminated sharps such as syringes and needles,
infectious empty vials, and blood soiled cotton
2. Non-hazardous wastes: the plastic wrapper, paper and cotton.

Guidelines on waste segregation and management are as follows:

1. Proper segregation of the waste at source or onsite shall be strictly followed.
2. Sharps such as syringes and needles shall be placed in a safety collection box for temporary
storage onsite and fill with chemical disinfectant when ¾ full.
3. Empty vaccine vials and used syringe barrels shall be considered infectious. The wastes shall
be placed in a separate waste bin lined with yellow plastic bad and with cover.
4. Both bins and plastic liners shall be preferably of the same color for the type of waste
intended to be placed. This is to avoid confusion and poor segregation.
5. The recommended thickness of the plastic liners is 0.07 mm (ISO 7765 2004). Plastics used
for either containers or bags should be chlorine-free. Not all plastic bags can withstand
temperatures of 121ºC, and some can melt during an autoclave process.

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 6. Proper tagging of plastic liners before placing on the waste bin is to be strictly implemented.
The tag of the plastic liner shall indicate the following: a) name of the health care facility or
implementing unit; b) area of the health care facility or implementing unit where the waste
was generated (or the source); c) type of waste and the weight and date of collection on-site,
or date and time of closure of the container; and d) name of the person filling out the label.
7. Containers should be large enough for the quantity of waste generated at that location
during the period between collections;
8. All filled waste containers shall be collected only by designated staff and brought to the
temporary storage area of the health care facility or implementing unit. The collected plastic
container shall be tied tightly.
9. All non-hazardous wastes shall be placed in separate waste bins together with the general
waste.

Guidelines on waste collection and transport are as follows:

1. The collection and transport practices shall be designed to achieve an efficient movement of
waste from point of generation to storage or treatment while minimizing the risk to the
personnel.
2. The general service personnel shall be assigned for the collection of wastes from the waste
bins going to the on-site storage area of the health care facility or implementing unit.
3. Infectious and general waste should be collected daily (or as frequently as required).
4. Waste bags should be filled to no more than three-quarters full. Once this level is reached,
they should be sealed ready for collection. Plastic bags should never be stapled but may be
tied or sealed with a plastic tag or tie.
5. Sharp containers should be collected when three-quarters full.
6. Upon waste collection, the personnel must ensure that the waste bags and containers are
properly labeled.
7. Replacement bags or containers should be available at each waste collection location so that
full ones can immediately be replaced.
8. Transport of the collected waste must be done using wheeled trolleys/carts or wheeled bins.
9. Hazardous and non-hazardous waste should always be transported separately.
10. Infectious waste can be transported together with used sharps wastes.
11. The trolleys shall be disinfected after every use.
a. Can be cleaned and disinfected daily using 4-5% concentration of sodium
hypochlorite (NaClO).

Guidelines on central storage are as follows:

1. All collected and transported waste materials shall be stored in the designated central storage
area of the health care facility.
a. There shall be separate storage area for hazardous and non-hazardous wastes.

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 2. Hazardous waste should always be stored in enclosed rooms.
3. The storage place must be identified as an infectious waste area by using the biohazard sign.

Guidelines on treatment and disposal systems. The following options for treatment and disposal of
all hazardous waste during vaccination may be applied:
a. Onsite system. The health care facilities or implementing units may construct concrete vault
within its premises to serve as the final disposal for the syringes and vials. The vault must be
constructed of concrete walls and slabs with a minimum size of 1m X 1m X 1.8m.
b. Offsite system. The health care facilities or implementing units may avail the service of a
DENR-accredited waste transporter to transport all the hazardous waste generated during
the vaccination to the final treatment and disposal facility.

Lastly, the estimated volume or amount of waste generated particularly the hazardous waste must
be recorded.

Reverse Logistics

The following are reverse logistics guidelines:

1. Empty and unopened vials should be returned daily by the Vaccination Team to the
implementing unit or RHU/CHO for consolidation.
2. At the end of each vaccination period, accounted empty/opened vials should be kept in a
safe and secured place in the health facility.
3. Unopened usable vials should remain stored at required temperature.
4. Properly accomplish Form A to await pick up by the CHD for destruction.

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Figure 16. Form A: End of vaccination period distribution and utilization report.

Computation and Terms

1. Calculate vaccine wastage rate: (number of vaccine doses used - number of eligible
population) / number of vaccine doses used x 100 = vaccine wastage rate (%)
2. “Vaccine doses used” includes doses used for immunization and all doses discarded or lost
for any reason (including expiry, indication of heat exposure, missing inventory, cold chain
failure, freezing or discarding of open vials of vaccine at the end of a session or campaign
activity).
3. The wastage rate is the percentage of vaccine doses that are wasted - in other words, doses
that are not used for immunization and are discarded or lost for any reason.

Retrieval of vials from the field

1. The vaccination team should return vials in re-sealable plastic bags (a maximum of 20 vials
per resealable plastic bag).
2. Supervisors should count collected empty vials at the end of vaccination day.
3. Empty vial retrieved should be well accounted and documented.

Vials accountability

Unaccounted vials should be:

1. reported to the supervisor.
2. reason/s for the unaccountability should be stated.
3. investigated with the support of the LGUs.

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 4. Incident report should be prepared and endorsed by the following: NIP, RHU, LGUs and
submitted to overseeing VOC.

Disposal of COVID-19 vaccine vials

These are the basic principles:

1. A detailed vial collection and destruction plan should be developed.
2. Destruction of the vials should be in accordance with national regulations.
3. Used/opened vials should be inactivated prior to destruction. The recommended
methods are:
a. Inactivation by autoclaving, boiling, chemical inactivation, encapsulation or
incineration.
b. Destruction and disposal by transporting to the waste facility or burying.

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Chapter 7: Assessment, Evaluation and
Monitoring
The post-implementation phase starts right after the first dose of vaccine is administered. This phase
has two components: the AEFI surveillance and response, and pharmacovigilance.

Vaccine Safety Monitoring, and Management of Adverse Events Following Immunization

The role of vaccine safety monitoring during COVID-19 vaccine introduction is to facilitate the
early detection, reporting, notification, investigation and analysis, and feedback of Adverse Events
Following Immunization (AEFIs) and Adverse Events of Special Interest (AESI), to ensure
appropriate and timely case management and response. These activities shall assist vaccinees and
ensure them of prompt and timely response should an AEFI occur.
The AEFI surveillance entails:
● Timely detection of serious AEFIs/AESIs to provide up-to-date and accurate data that can
be shared with relevant stakeholders for appropriate response;
● Generation of data to characterize the safety of the COVID-19 vaccines in use;
● Identification, investigation, assessment and validation of safety signals and
recommendation of appropriate public health interventions or other interventions; and
● High quality safety surveillance and maintenance of public and stakeholder confidence in
vaccines and immunization

The WHO defines Adverse Event Following Immunization (AEFI) as any untoward medical
occurrence which follows immunization, and which does not necessarily have a causal relationship
with the usage of the vaccine. If not rapidly and effectively dealt with, AEFIs can undermine
confidence in a vaccine and ultimately have dramatic consequences for immunization coverage and
disease incidence. Based on consultations with experts and the latest data from published clinical
trials as of 16 January 2021, the following are the identified AEFI from various brands of COVID-
19 vaccination and must be reported.

Table 32. List of Adverse Events Following COVID-19 Vaccination of Selected Candidate COVID-19 Vaccine.
Manufacture University of Oxford and Astrazeneca BioNTech and Pfizer NIAID and Novavax
r Moderna

Adverse Events*
Age 18-55 56-69 >70+ >18
Mild Moderate Severe
Pain at 75% 64% 63% 54% 34% 22% 84.1% 92.0% 45% 0% 0%
injection 39% 12.5%
site
Redness 7% 11% 12% 12% 11% 11% 9.5% 10.0% 0% 0% 0%

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Swelling 7% 7% 12% 12% 14% 14% 10.5% 14.7% 0% 0% 0%
Tenderness 87% 75% 83% 76% 64% 62% 19.8% 36% 16% 0%
45.8% 29.2% 4.2%
Warmth 27% 25% 22% 32% 27% 14%
Itch 14% 25% 22% 18% 14% 11%

Induration 7% 7% 12% 12% 11% 11%

Feverish 58% 22% 27% 32% 22% 20%

Fever 39% 7% 12% 12% 7% 7% 14.2% 15.5% 4.2%

Chills 50% 27% 27% 27% 14% 7% 31.9% 45.4%

Joint Pain 48% 17% 35% 36% 27% 20% 23.6% 46.4% 8.0% 4.2% 8.3%

Muscle 67% 52% 56% 44% 32% 32% 38.3% 61.5% 24% 8% -
Ache 37.5% 8.3% 8.3%

Fatigue 87% 69% 69% 61% 56% 48% 62.9% 70% 28% 12% 0%
25% 16.7% 8.3%

Headache 78% 45% 69% 54% 56% 34% 55.1% 64.7% 28% 4% 4%
41.7% 16.7% -

Nausea/ 41% 20% 31% 40% 20% 17% 1.1% 23% 12.5% 4%
Vomiting

Diarrhea 11.1% 10. 4% 8.2% 8.3%

Need for 27.8% 45. % 19.9% 37.7%

antipyretic

Malaise 56% 43% 46% 27% 39% 25% 0.5% 20% 8% 0%

12.6% 16.7% 8.3%

Manufacture University of Oxford and Astrazeneca BioNTech and Pfizer NIAID and Novavax
r Moderna

Serious 0.7% (84/12021) 0.4% (n=10841) 18-55 1.0% (n=147)

Adverse 0.8% (n=7960) >55
Events*
Event-
based

● haemolytic anaemia in the control group Related to vaccine: ● Lymphadenopathy 1.1%

● Neuroinflammatory disorders ● 1 Lymphadenopathy ● Hypersensitivity:1.5%
● Transverse myelitis which is likely to be ● 1 Shoulder injury due to incorrect (injection site rash and injection site urticaria)
idiopathic, short segment, spinal cord administration ● 3 cases of Bell’s palsy
demyelination ● Unsure ● Facial swelling
● Fever higher than 40°C ● Appendicitis ● Intractable nausea and vomiting in a
● Deaths ● Facial paralysis (Bell’s palsy) participant with prior history of severe
● Road traffic accident, blunt force trauma, ● G51.0 7,400 headache and nausea requiring
homicide, and fungal pneumonia ● Ventricular arrhythmia hospitalization.
● I47.0 12,200
● pain in the lower
back/extremities/and radicular
paraesthesia
Coincidental
Active group
● 1 Anaphylactoid reaction (related to
bee sting)
● 1 Drug hypersensitivity
(doxycycline)
● T78.2 Anaphylaxis 7600
Placebo group
● 1 Anaphylactoid reaction due to ant
bite

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 ● 16-17 years old
● 1 facial bone fracture
● Deaths
● 7 deaths (2 active 4 placebo)
● Due to pre-existing diseases
including aortic rupture

Special ● Elderly: safety data limited in >65, no ● Pregnancy: very limited ● For use in individuals 18 years of age and
popula- dosing adjustments ● Elderly: no specific safety concern older
tion ● Pediatric: no data available ● Immunocompromised: on stable ● Elderly >65
ART for 6 months, ● No notable differences in the safety
● Pediatric: limited participants profiles

As can be seen on the table above, the AEFIs are divided into two groups. Minor AEFIs are local or
systemic signs and symptoms that easily resolve within a few days without medical intervention and
do not pose a potential risk to the health of the vaccinee. On the other hand, serious AEFIs are events
that cause a potential risk to the health/life of a vaccinee leading to hospitalization, disability/
incapacity or death. A thorough investigation and retrieval of medical records are critical to
determine whether the adverse event has been caused by the vaccine, immunization error or from
programmatic errors.

In addition to AEFIs, Adverse Events of Special Interest (AESIs) arising from COVID-19
vaccination must also be reported. The Council for International Organizations of Medical Sciences
(CIOMS) VII defines AESI as a scientific and medical concern specific to the sponsor’s product or
program, which can be serious or non-serious, and for which, ongoing monitoring and rapid
communication by the investigator to the sponsor could be appropriate. Such an event might
require further investigation in order to characterize and understand it. Depending on the nature of
the event, rapid communication by the trial sponsor to other parties (e.g. regulators) might also be
warranted. While AESIs are also considered important in surveillance and response, the STG has yet
to formalize the list of AESIs that are deemed reportable. The following are AESIs being considered:

Table 33. Adverse Events of Special Interest relevant to COVID-19.

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In the context of the COVID-19 vaccination program, any health event that has occurred after
vaccination must be reported and considered as AEFI, pending proper professional
consultation/case classification.

AEFI surveillance shall be performed by the Surveillance Officer (stimulated passive surveillance)
every two (2) weeks for the first two (2) months, then monthly for one year. This is to ensure that
no health event relevant to COVID-19 shall be experienced by the recipient per incubation period
of the disease.

Passive surveillance requires empowering and reinforcing the vaccinee to report any health event
post-vaccination. There are two advantages to passive surveillance: 1) it may lower healthcare system
burden since minor cases are catered by lower level health facilities, while higher level health facilities
concentrate on treating serious AEFIs only, 2) the detection and reporting of all AEFIs, especially
minor ones, will allow greater chance of detecting minor clusters of AEFIs, which will, in turn, be
reported as part of global knowledge on vaccines.

Figure 17 shows the process flowchart for AEFI surveillance and response for COVID-19
vaccination. Following vaccination, the Surveillance Officer shall follow-up the vaccinee, and
rematch him/her with his/her pre-existing conditions. If the Surveillance Officer identified
additional findings, he/she shall provide immediate appropriate treatment and facilitate transfer to
an identified referral facility, if necessary. If there are no additional findings, he/she shall check for
AEFIs and classify the vaccinee as one of the following: (1) well (no AEFI), (2) minor AEFI and (3)
serious AEFI.

In addition, the vaccinee can also report his/her signs and symptoms (self-reporting) by, a) calling
the VOC Call Center, b) filing a report to FDA through the pharmacovigilance system or directly
to the vaccine manufacturer, or c) reporting online (a system, similar to the of COVIDKaya, shall
be set up). These mechanisms shall be aligned with the masterlisting and profiling data to ensure
continuity of data and harmonization through the overarching Vaccine Information Management
System (VIMS).

Figure 17. Process flowchart for AEFI surveillance and response in the context of COVID-19 vaccine administration.

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The Surveillance Officer, as part of the AEFI/AESI Composite Team assigned in the post-
vaccination monitoring area, shall provide information to the vaccinee on existing procedures and
protocols in identifying and reporting AEFIs, especially serious cases.

For the routine follow-up for the vaccinee, the Surveillance Officer shall be stationed in the facility
as part of the Human Resource/Administrative Department of the facility equipped with the
necessary information communication technology equipment for performing its follow-up
function to vaccinees. Methods of following up may be stratified phone calls, facility
announcements/ memorandums, through notes upon receipt of documents/salary papers by the
facility, etc.

For minor AEFIs detected through self-report or SSO assessment, QR code verification must be
done by the responsible health facility. If the vaccinee with minor AEFI was deemed in need of
medical assistance, he/she must be promptly referred to the identified health facility for
management. If there is no need for medical assistance, he/she must be given medical advice,
followed by an updating of the QR profile (Figure 18).

Figure 18. Process flowchart for responding to minor AEFIs of COVID-19 vaccine.

Serious AEFIs should further be investigated and reported through the Event-based Surveillance
Reporting System. All serious AEFIs must be given prompt and appropriate care at a health facility,
followed by investigation of the case and submission of data to the AEFI database. During
investigation, initial causality assessment shall be done by the Regional AEFI Committee (RAEFIC).
Based on this assessment, the final causality assessment shall be done by the National AEFI
Committee (NAEFIC). Based on the final cause determined, the NAEFIC shall provide
recommendations to the Epidemiology Bureau, Food and Drug Administration, National
Immunization Program and Centers for Health Development for appropriate action. Response at
the regional level shall also be assisted by the National AEFI Response Team. If the vaccine recipient
does not recover and dies, further investigation of the death shall be conducted (Figure 19).

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Figure 19. Process flowchart for responding to serious AEFIs of COVID-19 vaccine.

Additionally, the WHO recommends safety surveillance activities for all countries introducing
COVID-19 vaccine, regardless of AEFI surveillance capacity. These are summarized in Table 35
below.

Table 34. WHO-recommended safety surveillance activities for all countries introducing COVID-19 vaccine regardless
of AEFI surveillance capacity.
Objective
Strengthen routine passive
AEFI surveillance reporting
systems for the
management of increased
frequency or severity of
AEFI reports (mild,
moderate and severe)
Investigate potential AEFIs
causing concern, such as
clusters, serious events,
Recommended AEFI surveillance activities
● Conduct training on identification and reporting of AEFI for
health care professionals.
● Update, print and distribute AEFI surveillance tools.
● Use both vaccine tracking information and passive AEFI reporting information
to perform vaccine-specific safety analyses.
● Review and adapt processes for timely reporting, review and data sharing
nationally, regionally and globally (e.g. uploading data to global databases such
as the WHO VigiBase)
● Develop clear standard operating procedures (SOPs) for the coordination
process between the NRA, NIP/EIP, and other institutions with responsibilities
for AEFI surveillance.
● Consider coordination of activities with Public Health Emergency Units.
● Consider setting up AEFI committees at subnational as well as national level,
particularly in large countries
● Prepare investigation teams and train them for AEFI investigation activities that
are relevant in the population being vaccinated.
● Update, print and distribute AEFI investigation tools to obtain information on
specific outcomes.

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 programmatic errors,
community concerns
Perform systematic
causality assessment of
AEFIs causing concern
Use AEFI and disease
surveillance data to detect
potential safety signals or
clustering of events
Prepare comprehensive
plans to respond rapidly to
any COVID-19 vaccine-
related event
Address concerns of
healthcare professionals
and maintain community
confidence. (Link to
communication module to
be added)
● Ensure the collection and storage of all relevant data to help make a causality
assessment (AEFI reporting and investigation forms, clinical case record,
laboratory reports, autopsy reports, etc.)
● Constitute an National AEFI committee to review and respond to AEFI safety
signals and public concerns or contact the WHO Country or Regional Office
or send email to gvsi@who.int for assistance.
● Provide training on causality assessment processes using WHO causality
assessment guidelines for members of the National AEFI committee.
● Ensure regular updates to the Committee members on COVID-19 vaccine
development and safety data, including safety reports from ongoing phase III
clinical trials or any events reported in clinical trials.
● Foster and use the committee’s expertise to identify AEFI cases in need of further
investigation, such as AESIs. 5. Anticipate an increased number of AEFI reports
that will need to be reviewed and consider including AEFI committees at
subnational as well as national level, particularly in large countries.
● Regularly review and report AEFI surveillance data, particularly those relevant
to AESIs or other conditions identified during pre-licensure COVID-19 vaccine
clinical trials.
● Explore the use of disease surveillance data to complement AEFI surveillance
systems for the detecting of AESIs, if indicated.
● Consider use of early signal detection methods, especially for certain AESIs.
● Outline roles and responsibilities of key stakeholders (including the private
sector) for the implementation of safety surveillance activities and responding to
vaccine-related events.
● Keep stakeholders up to date with COVID-19 vaccine safety information.
● Communicate with WHO regions and globally and share data on outcomes of
AEFIs and AESIs in a rapid, timely and regular manner.
● Create and share a COVID-19 vaccine safety communication plan with relevant
stakeholders.
● Train and support personnel at all levels to address concerns that may arise
before, during and after COVID-19 vaccine introduction.
● Develop, print, and distribute messages concerning the safety COVID-19
vaccines

Note: Objectives and Recommendations were adapted from the WHO COVID-19 Vaccines Safety Surveillance Manual:
Module on Establishing surveillance systems in countries using COVID-19 vaccines, 2020.

Serious AEFIs and AESIs are events that result in death, are life-threatening, require in-patient
hospitalization or prolongation of existing hospitalization, result in persistent or significant
disability/incapacity, or cause congenital anomalies or birth defects. If serious AEFIs or AESIs occur,
all documentation generated during the management of the event, including hospitalization, should
be appended to the investigation form and submitted as a dossier to the NAEFIC for causality
assessment. The risk communication team should be made aware of the occurrence as soon as
possible.

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Specific protocols for investigating deaths following COVID-19 vaccination shall be defined.
Guidance on investigating deaths following vaccination are provided in the global guidelines on
AEFI surveillance. Deaths of individuals who received COVID-19 vaccines, including those
classified as AESI, shall be included in the protocol for investigating deaths following COVID-19
vaccination.

Coordination with stakeholders reporting COVID-19-related deaths as well as COVID-19

vaccination-related deaths should be established. Protocols that were developed for investigating
COVID-19 related deaths could be adapted in the investigation of COVID-19 vaccination related
deaths. If indicated, tissue samples should be collected for in-depth pathologic, virologic and genetic
testing. If an autopsy is not done, a complete verbal autopsy using standard protocol should be
conducted and the findings documented and sent to the national AEFI committee.5

Safety Surveillance and Response

Enabling Policies and Guidelines

The guiding principles for Safety Surveillance and Response is based on the World Health
Organization (WHO) Strategic Advisory Group of Experts on Immunization (SAGE) Values
Framework for the Allocation and Prioritization of COVID-19 vaccination published last
September 2020.

Existing policies for AEFI surveillance and response such as Administrative Order (AO) No. 2016-
0006, or the Revised Guidelines on Surveillance and Response to Adverse Events Following
Immunization details the general and specific guidelines on performing AEFI surveillance and
response. For case management and support, AO No. 2016-0025, or the Guidelines on the Referral
System for Adverse Events Following Immunization (AEFI) of DOH Programs can be used as
reference. Furthermore, the AEFI Manual of Procedures published last 2014 by the DOH provides
the overall operational guidelines for AEFI surveillance and response.

Other supportive administrative issuances include the following:

(1) Department Memorandum (DM) No. 2011-0308, or the Strengthening Adverse Events
Following Immunization (AEFI) Surveillance and Response at all levels (Annex 7-D) is an important
policy prior to the Data Privacy Act of 2013. The policy requires health facilities to submit all
medical records of those referred for AEFI cases. However, the DM requires amendment and
alignment with RA 11332, or the Mandatory Reporting of Notifiable Diseases and Health Events of
Public Health Concern Act and its 2020 Revised Implementing Rules and Regulation wherein AEFI

5
Adapted from WHO COVID-19 Vaccines Safety Surveillance Manual: Module on Establishing Surveillance
Systems in countries using COVID-19 vaccine

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is listed as one of the immediately notifiable diseases were notification is required at all levels within
24-48 hours upon identification and detection.

(2) DM 2020-0459 or the Reiteration on the Implementation of AO No. 2016-0006, and AO No.
2016-0025, reiterated the role of DOH EB and its regional counterparts on AEFI surveillance.

Restructuring of the National AEFI Committee through DPO No. 2020-2996 as an independent
expert panel for causality assessment of serious AEFI cases. The NAEFIC members include pediatric
infectious diseases experts, vaccinology experts, forensic pathology experts, immunologist and
allergologist among others. Technical resource persons can also be invited (e.g. adult infectious
disease experts).

To support the NAEFIC, the National AEFI Response Team through DPO No. 2020-2772 was
created with the composing of the following: EB, DPCB, FDA, HPB, RITM, HEMB.

Regulatory provisions requiring manufacturers to implement risk management plans and

collect and report COVID-19 vaccine safety data to the NRA

The Risk Management Plan (RMP) provides a detailed description of the risk management system
for a certain product. It is a set of pharmacovigilance activities and interventions designed to identify,
characterize, prevent or minimize risks relating to pharmaceutical products including the assessment
of the effectiveness of those interventions.

Before a drug product is authorized, the FDA requires submission of the Risk Management Plan
(RMP) as part of the company’s obligation on the use of their product. Specific pharmacovigilance
requirements and obligations are stipulated in FDA Circular No. 2020-003 Guidelines for
Pharmaceutical Industry on Pharmacovigilance.

The RMP contains important information with regards to the safety of the product such as product
overview, safety specification (important identified risk, important potential risk and missing
information), the proposed pharmacovigilance plan, and proposed risk minimization measures.
Routine pharmacovigilance activities include collection and reporting AEFI to the FDA, signal
detection and updating of significant information as well as reporting action taken by other
regulatory agencies in other countries. Other than routine is an additional pharmacovigilance
activity which may include non-clinical studies, clinical trial or non-interventional studies aiming to
further identify and characterize the risks of the product.

For the purpose of transparency and risk minimization, the summary of the RMP and its updates
may be uploaded in the FDA website as reference in immunization programs. The FDA shall ensure
availability of these information. Information related to the risk of vaccines shall be coordinated to
the TG for Demand Generation and Communication for proper communication and

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dissemination. Dissemination fora shall be scheduled in order to inform all relevant stakeholders on
the prerequisites and foreseen processes related to risk management plans.

Any other policies deemed necessary in order to properly implement the COVID-19 vaccine
immunization plan will be developed and crafted in relation to AEFI surveillance and response.

As part of the preliminary regulatory measure, the FDA Circular 2020-036 on the Guidelines on the
Issuance of Emergency Use Authorization for Drugs and Vaccines for COVID-19 stipulated the need
of the market authorization holder to have a comprehensive pharmacovigilance system for their
product following the system or protocol of a registered drug or biological product which includes
assistance to the national initiatives on AEFI surveillance and response system.

AEFI Surveillance Cycle

In order to contextualize the operational guidelines from AEFI to have a special focus on COVID-
19 vaccination, the components of the AEFI Surveillance Cycle based on the World Health
Organization (Figure 13). Guidance for establishing AEFI surveillance systems shall be illustrated
for the succeeding activities.

Figure 20. AEFI Surveillance Cycle.

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Table 35. The AEFI Surveillance Cycle components.

AEFI Surveillance Cycle Main points

components

1. Identification ● Health care providers, vaccinators and personnel from the field
● Individuals who received the vaccination
● Researchers, sponsors, investigators and laboratories involved in clinical
studies or field trials
● Vaccine manufacturers and distributors

2. Notification ● Minor AEFI cases reported weekly to the higher ESU level. (shift to daily
for COVID-19 vaccine)
● Serious AEFIs and clusters of minor AEFIs are reported within 24 to 48
hours simultaneously to higher level ESUs and the EB for case
investigation.

3. Reporting ● Minor AEFI through Case Report Form and Vigiflow

● Serious AEFI through Case Investigation Form and Vigiflow

4. Investigation ● Only serious AEFI and clusters of minor AEFIs needed to be investigated
● SOP on handling Serious AEFI cases needed to be filled up and submitted
to EB as soon as possible
● Case Investigation Form within 24-48 hrs

5. Analysis ● Daily bulletin

6. Causality Assessment
● All serious AEFI cases or clusters of minor AEFI should have
comprehensive AEFI investigations and for endorsement to RAEFIC and
forwarded to NAEFIC
● For those regions without RAEFIC, AEFIs are forwarded directly to
NAEFIC for causality assessment

7. Feedback ● All final resolutions shall be issued by the NAEFIC

● RAEFIC resolutions shall be based on the approved official documents of
NAEFIC for dissemination
● Risk communication before, during, and after AEFI cases shall be made.
● Post-incident evaluation shall be spearheaded by RAEFIC.
● CHDs to monitor and evaluate RAEFIC / NAEFIC recommendations

In line with the components of the AEFI Surveillance Cycle: AEFI identification relies on the ability
and initiative of AEFI reporting units/facilities to proactively identify AEFI whether it would be a
minor or serious case. With this, a series of orientation sessions and refresher courses on vaccinators
and officers in disease reporting units shall be informed that any health event that has occurred after
vaccination must be reported and considered as AEFI pending proper professional
consultation/case classification. In line with this, training modules shall be developed including
FAQs on the vaccine which will be guided by WHO partners.

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AEFI notification and reporting currently has a working system in place through Event-based
Reporting System wherein all AEFI cases must have an accomplished ESR form submitted to the
higher level Epidemiology and Surveillance Units weekly, whereas all serious AEFI cases must be
notified to all higher level ESUs and EB within 24-48 hours. Training modules shall also be
developed to ensure the alignment of reporting of AEFI of a novel vaccine to the existing system.

The development of training modules shall be based on existing manuals and guidelines; the list of
manuals includes the following but are not limited:
a. DOH AEFI Manual of Procedures
b. DOH Event-based Surveillance (ESR) Manual
c. DOH Philippine Integrated Disease Surveillance and Response (PIDSR)
d. WHO Causality Assessment Manual 2nd edition
e. WHO Global Safety Surveillance Manual
f. WHO COVID-19 Safety Surveillance Manual
g. WHO National Vaccine Development Program

The National AEFI Committee (NAEFIC) conducts a systematic review of data about AEFI case(s)
to determine the likelihood of causal association between the event and the vaccine(s) received. The
readiness of the Regional AEFI Committee (RAEFIC)s were assessed through DM 2020-0415,
wherein most of the regions have functional RAEFICs. As part of the follow-up action, regions
needing further technical assistance shall accomplish a needs assessment tool through DM 2020-
0508.

In coordination with WHO, training materials for COVID-19 vaccination include Instructor-led
and Online self-learning. Some of the materials may be accessed from:
a. WHO e-Learning Course on AEFI Investigation e-Learning course: Investigating Adverse
Events Following Immunization (AEFI) (vaccine-safety-training.org)
b. Causality assessment algorithm and WHO e-tool: http://gvsi-aefi-tools.org/
c. Global Vaccine Safety – E-learning course on Vaccine Safety Basics WHO | E-learning
course on Vaccine Safety Basics
d. COVID-19 technical resources: page:https://www.technet-21.org/en/topics/covid-19

AEFI Reporting uses the current Event-based Surveillance Reporting and Philippine Integrated
Disease Surveillance and Response (PIDSR) reporting system. However, with the novel vaccine
pressing a concern on interagency operability of current systems and data sharing, a comparative
evaluation of the Excel format utilized during the Measles-Rubella-Oral Polio Vaccine
Supplemental Immunization Activity (MR-OPV SIA) and VigiFlow was done (Table 36). Based on
the Center for Disease Control criteria for surveillance, VigiFlow, which is currently being
recognized as the global standard, managed by WHO and Uppsala Monitoring Center, shall be used
as the National COVID-19 AEFI Surveillance System. Moreover, the AEFI template was recently
added and training of national and sub-national level staff was already performed. Moving forward,

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more simulation exercises to ensure smooth usage of the VigiFlow shall be the next priority along
with providing access to the determined reporting units.
Table 36. Comparative evaluation of excel format and VigiFlow.
Criteria adapted on Current System (Excel
CDC Evaluation of Template)
Surveillance Systems
Simplicity: refers to both the structure and ease of operation of surveillance system
Ease of navigation and User friendly, simple and
data entry and uploading beginner level. Advantage
of documents. is familiarity with Excel
interface.
AEFI excel template was
based on the core variables
of Case Report Form and
Dengvaxia vaccine AEFI
reporting template.
Feasibility of training One training session was
schedule with the sufficient for RESUs to be
current timelines for able to submit the
COVID-19 vaccination accomplished tool weekly
Time spent with Data cleaning of 50 AEFI
maintaining the system, cases (line listing and
collecting, transmitting, sending to regions for
analyzing case verification) and
information, and generating statistics as
preparing and draft AEFI surveillance
disseminating report takes one man day
surveillance reports
Bottleneck processes
include time to verify and
sending of reports by the
regions and LGU level
VIGIFLOW
Fields are easy to understand.
Some fields have drop-down
options. There is a
navigation panel for ease of
jumping to specific parts of
the report. MedDRA and
WHO Drug coded.
However, no uploading
capability.
Online training (recorded) is
available on the UMC
website. The FDA PV team
may also provide training for
new users.
VigiFlow Training Materials
https://www.who-
umc.org/global-
pharmacovigilance/vigiflow/
training-materials/english/
No maintenance is necessary.
Collecting and transmitting
of data is real time. Reports
may be downloaded into
excel or pdf files.
REMARKS
The current excel template
is currently being used by
the RESUs which are the
main AEFI surveillance
system at the moment.
Navigation of VigiFlow
will require additional
orientation training which
should be scheduled early
January 2021
The Excel tool is self-
explanatory and will not
be overwhelming.
Training schedules for
Vigiflow must be set
immediately as well as the
targeted people to access
VigiFlow to preserve data
integrity.
The maintenance of the
system for excel heavily
relies on the national data
managers. Whereas, for
vigiflow, it is the accepted
system in the WHO
setting and global level.
Familiarization and data
encoding may bear more
time for Vigiflow
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Minimum technical Downloaded and saved Computer (laptop or PC) Main advantage of excel:
requirement of the into a local PC and internet connection are off line functionality
device (PC/Laptop) drive/laptop with the minimum requirements.
Microsoft Excel No local installations, back-
application (93 version ups or maintenance are
and above) for encoding. necessary. No off-line
functionality.

Flexibility: observing how a system responded to a new demand

Able to accommodate, The system is adept to be May be accommodated in Revising specific variables
for example, COVID-19 incorporated to any the global level through the for COVID-19 to fit
vaccine (novel vaccine), vaccine with minimal edits UMC. COVID-19 vaccine is national needs is easier in
changes in case on the needed variables coded into WHODrug. AEFI excel.
definitions, and specifically for COVID-19
Data sharing for global
variations in reporting vaccine. Currently limited
level is already set up in
sources platform for global data
Vigiflow
sharing. Used through
google sheets / excel.

Acceptability: willingness of individuals and organizations to participate in the surveillance system

Participation rates All the RESUs and CHDs Hospitals who regularly A consensus on the
among internal and are responsive and able to report to the FDA were national level must be
external comply with the weekly given VigiFlow accounts and built to roll out the
stakeholders/partners submission of their are already using the system specific database that the
accomplished Excel in reporting. facilities and ESUs will use
Templates.
Pharmaceutical Companies
have a system that generates
reports in E2B xml files
which are then uploaded to
the VigiFlow either manually
by the FDA or directly
through eReporting for
Industry.

Health care professionals,

non-health professionals &
patients may report through
the eReporting system.

Completeness and There are only some There are several fields that Due to the nature of excel
timeliness of reporting regions that submitting are needed for a report to be reporting, there are great
accompanied with complete and on time submitted to the VigiFlow instances wherein
seeking technical reports such as the minimum incomplete data are
mandatory information. submitted. No mechanism

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support in Data submissions of
troubleshooting RESUs and CHDs every
week then followed by
data verification and
validation by EB. There
are incomplete and
delayed submissions in
some regions.
Sensitivity: ability to be detected by the surveillance systems and to detect epidemics
Predictive value positive: proportion of persons identified as having cases who actually do have the
condition under surveillance
Confirmation of cases The current system is cross
reported through the validated with Event-based
surveillance systems Surveillance System and
(Event-based RESU for confirmation of
Surveillance Reporting cases
and AEFI system)
Quality of data: clarity of surveillance forms, complete surveillance forms and appropriate data
management
Completeness of WHO Additional variables
core variable for AEFI needed can be easily
reporting integrated in the Excel
Template.
Although based on the
WHO core variables for
AEFI, it may be tailored to
fit contextual purposes
Reports submitted are is set to have minimum
received real time by the data requirements.
FDA.
Validation mechanism of
Technical support in
reports submitted to FDA
troubleshooting may be
should be strengthened in
provided by the FDA PV
the regional and national
Team.
level.
Real time reporting that may
have pressing concerns on
accurateness and
accountability of data
submitted.
Cases are presented in line
list coded in MedDRA
terminologies
Pilot testing of the AEFI
Vigiflow shall commence in
January 2nd week of 2021
VigiFlow are made for Vigiflow current has a
reporting adverse reactions Demo version specifically
including adverse events targeting AEFI reporting
following immunization. To
adapt the current situation AEFI excel was enhanced
on COVID-19, UMC is to fit the HWO Core
currently developing the Variables for AEFI
VigiFlow system to enhance reporting
the core variables for AEFI
reporting. The target release
of these developments is on
the 2nd week of January.
https://www.who-
umc.org/media/165550/usi
ng-vigiflow-for-data-
collection_covid-19.pdf
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Data gathered are easily
converted, merged and
integrated to the
platform
Able to produce meaningfulManually performed by
analysis,
Evaluation, and
assessment; or only with
desired variable/s
Timeliness: reflects the speed or delay between steps in a surveillance system
Ability to support the
24-48 hr reporting from
ESU to EB for
serious/clusters of minor
AEFIs
Timeliness of producing
reports (i.e. daily reports)
Traceability: ensure appropriate platform access on the national and sub-national levels
Security/Confidentiality of the Data
Can the end user update
the submitted
information?
Manually performed by
data managers
data managers therefore
able to tailor the needed
analysis given that
sufficient variables are
present
It can also supports the 24
– 48 hours reporting from
ESU to EB.
Can produce daily reports.
Weekly reports are drafted
within a day. Delayed data
submissions of RESUs
and CHDs are included in
the next report.
Yes, the end user can
update the submitted
information and leave a
remarks regarding to the
information that was
being updated
see above
Minimum required
information is necessary to
successfully save and submit
a report.
https://www.who-
umc.org/global-
pharmaovigilance/vigiflow/v
accine-surveillance-in-
vigiflow/
Real-time submission. Once
the report is saved, it is
readily available for the
higher levels (regional or
national level) to view or edit
the report.
Once a report is submitted, it
is ready to be generated.
Reports submitted through
the VigiFlow may be
updated/edited anytime.
Vigiflow is adept to
perform data analysis of
the entries
In AEFI excel, the data
managers and data analysis
team will have to manually
calculate and compute.
Both platforms contain
necessary variable in order
to perform minimum
required analysis
AEFI excel template relies
heavily on the timeliness
of submission by
stakeholders
In vigiflow, the same
scenario but with real time
reflecting submission
Both types of reports may
be easily edited and
updated
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 The end user has a direct
access to the Excel
Template and can update
all the information
previously encoded.

Yes, there is column for Yes. The date and name of Traceability of whom
Is it traceable? (shows the name of encoder and the person who last edited edited is more seen in
the name who updated column for date encoded. the report is reflected in the Vigiflow
the information and the It can also use the report.
date it was edited) REMARKS column for
any update information.

Includes the name of the

encoder and date encoded.
The name who updated
the information and the
date it was edited may be
included in the remarks
column.

It is manually determined
rather than system
generated

There is no user login for

better traceability
function

Ability to have It can access down to the The VigiFlow has 3 level Platform access
predefined data platform municipal, provincial and options to view/edit reports. mechanism is yet to be set
access per ESU level regional level. The Viewing or editing data on Excel template unlike
(only authorized interface is easy to use. depends on the level of in Vigiflow
personnel able to view access given to a specific
However, it may be still
and/or edit the data) accounts.
prone to errors when not
cascaded properly to the
lower level ESUs. Platform
access is dependent on the
capabilities of ESUs and
persons-in-charge

Due to the nature of the novel vaccine and the inclusion of adult population on the list of vaccinees,
series of trainings and encoding workshops will be conducted. The personnel involved in the
encoding of reports shall be formalized through an issuance of database logger in order to preserve
data integrity and traceability of surveillance reports. Accountability of the surveillance officer is also

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included in the training since data shared through the database will be disseminated to global level
for our country to participate and have access also to the latest updates on the possible signals of
AEFI for the novel vaccine.

Continuous harmonization of the surveillance platform is also on its development in terms of

linking the registry or the vaccinee profile with the AEFI. A unique identifier code shall be its
interoperability mechanism to link with the AEFI system. In order not to overload the health system
to all AEFI cases (minor and serious), a self-report mechanism for minor AEFI cases shall also be
developed which may be adapted to the current COVIDKAYA self-reporting platform. The
automated linkage of unique identifier code shall be enhanced within the next weeks during pre-
testing of the system. Furthermore, the AEFI surveillance and response systems are in the process of
interlinking through using a single database platform with both EB (PIDSR) and FDA as national
data managers. As mentioned, VigiFlow training, especially on AEFI reporting form which was
recently added in the system was cascaded to the national and subnational staff. Furthermore,
meetings with the Uppsala Monitoring Center pharmacovigilance team were already performed in
order to provide inputs on the improvements on the system and enhance the applicability of the tool
esp in data security, accessibility, data management in the Philippine Health system.

Strengthening AEFI investigation procedures requires series of orientation and capacity training on
the needs and actions of the AEFI investigations team (Epidemiology and Surveillance Unit, EPI
Coordinator/Cold Chain Manager, Food and Drug Regulation Officer, Health Promotion Officer)
on conducting field investigations for AEFIs. Moreover, enhancing the appropriate case
management and program support to those affected by serious AEFI or AEFIs needing professional
assistance is critical for service delivery.

In terms of response, the NART which is a composite team of DOH offices serves as the link to every
office in responding to emergency situations. To streamline the referral system, for AEFI cases and
optimize the use of medical care services at a national level for a unified NART response, the One
Hospital Command System (OHCS) shall be utilized (i.e. DO No. 2020-0653 - Guidelines in the
Creation of the One Hospital Command System, and DO. No. 2021-0004 - Delineation of Functions
of Hospital Oversight in Alignment with Universal Health Care). Further, the OHCS can be
supported by the Health Care Provider Network under AO No. 2020-0019 - Guidelines on the
Service Delivery Design of Health Care Provider Networks.

The Health Emergency Management Bureau along with the help of Field Implementation and
Coordination Team shall be the forefront offices in coordinating and determination of ambulance
services and designation of public and private facilities as AEFI referrals subject to the funds of
PhilHealth through case rates, or the Quick Access Fund of the National Agencies/Regional
Offices. For case management, costing estimates were calculated for minor and serious AEFI cases
with the projections for minor AEFI at 2% and serious at 0.16 per 100,000 doses (based on the

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National serious AEFI rates as per WHO and DOH assessment in 2013). Scenario-based analyses
were calculated based on the % population of vaccinees at 20%, 60%, and 70%.

As for the AEFI analysis, the current templates on vaccine surveillance reports are being enhanced
pending the important data needed to be analyzed specifically for COVID-19 vaccine. Currently,
the following variables considered in the recently concluded MR-OPV SIA Phase 1 campaign
includes the following:
● National and regional AEFI rates per 100,000 doses
● Profile of cases (age, sex, region, most common signs and symptoms)
● Rates of signs and symptoms per 100,000 doses
● Narrative profile of deaths

Feedback and risk communication before, during and after the vaccination program is critical in
order not to cause mass hysteria and public panic on COVID-19 vaccine. Thus, it is recommended
that the Health Promotions Bureau will handle this matter appropriately.

In terms of the surveillance flow, the interim proposal is status quo which states that for HCW,
senior citizens, and indigents on AEFI reporting system through health facilities and ESUs; as for
NGAs: geographical jurisdiction to respective ESUs (Figure 21).

Figure 14. Surveillance referral flow.

Identify and secure channels of data sharing mechanisms to share COVID-19 vaccine safety
data and findings with relevant regional and international partners: The International
Health Regulation (IHR) National Focal Point shall make the necessary coordination mechanism
with global and international partners in accordance with IHR guidelines and procedures. The IHR

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shall manage all communications and relay to relevant offices, task groups, in charge of the query
and shall consolidate all opinions and answers of the offices for their official reply.

The IHR National Focal Point acts as the international Liaison Officer for COVID-19 surveillance
and manages all communications of the AEFI surveillance with international partners. The team
shall respond within 24 hours upon receipt of any query.

The FDA, as a member of the WHO Programme for International Drug Monitoring, shall share
relevant cases of AEFIs to the global database of adverse drug reaction to facilitate data sharing and
analysis of data in the global context.

Monitoring and Evaluation Framework, and Reporting Mechanism

Prior to vaccine introduction, listing the various stakeholders, their roles and responsibilities in
handling end-to-end COVID-19 vaccine safety issues will help to shorten the response time during
a crisis and ensure that there is a harmonized approach to routine activities and managing a crisis and
unexpected events.

As COVID-19 vaccines are being introduced, there will likely be an intense demand for data by
different stakeholders, to meet the key anticipated needs of these different stakeholders, the
COVID-19 Vaccine Deployment and Vaccination Program monitoring system for COVID-19
vaccines has been designed to be able to:

● Measure equitable uptake and coverage over time by geography, population groups, and risk
groups.
● Monitor to what extent national policies to prioritize at-risk groups and settings (e.g.
hospital and long-term care facilities) are effectively implemented.
● Provide a personal vaccination record/certificate for any health, occupational, educational
and travel purposes (as per national policies).
● Ensure that the necessary records and documentation are in place for use in surveys, safety
monitoring, disease surveillance and vaccine effectiveness studies.
● Ensure that individuals can be monitored for the full course, in the likely case that a
multidose schedule is required, to reduce the incidence of drop-outs.

The main indicators to measure progress with COVID-19 vaccines are similar to any vaccine
introduction:

Vaccine uptake: The number or proportion of people vaccinated with a certain dose of the vaccine
in a certain time period (e.g. during a month or year). If expressed as a percentage, an alternative term
to be used is vaccination rate.

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Vaccination coverage: The vaccinated proportion of a target population, which is similar to
uptake, but considers vaccination in previous time periods. Over time, coverage can be constructed
by accounting for uptake in previous time periods (weeks, months, years), depending on the
duration of protection of the vaccine. For the year of introduction (2021), uptake and coverage can
be used interchangeably.6

Table 37. Dimensions for disaggregating vaccine uptake and coverage .

Continuous monitoring for situational awareness throughout the COVID-19 Vaccination Program
is crucial for a successful outcome. Prior to receiving COVID-19 vaccine, jurisdictions should
establish procedures for monitoring various critical program planning and implementation
elements, including performance targets, resources, staffing, and activities.

To provide situational awareness for higher officials and the general public throughout the COVID-
19 vaccination response, the following dashboards will be available:
● Weekly COVID vaccination dashboard
● COVID-19 vaccine distribution planning, tracking, modeling, and analysis application

Evaluation of COVID-19 vaccine introduction

Based on the World Health Organization’s “Guidance on developing a national deployment and
vaccination plan for COVID-19 vaccines”, evaluation of COVID-19 vaccine introduction pertains

6
Adapted from the WHO Interim Guidance on developing a national deployment and vaccination plan for
COVID-19 vaccines, 16 November 2020

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to the “post-evaluation following the introduction of COVID-19 vaccines to assess vaccine
effectiveness impact and identify any improvements to the COVID-19 vaccination process”. This
may cover (a) assessment of the impact of the specificities and novelty of the COVID-19 vaccines
on the immunization program and how these will input to the further optimization of the vaccine
deployment, (b) assessment of vaccine effectiveness and impact after introduction into populations,
and (c) documenting the lessons learned from deployment and vaccination operations.

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